Chorea Associated With Huntington Disease
Conditions
Keywords
Chorea, Huntington Disease
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in Switch participants as well as Rollover participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.
Interventions
DRUGSD-809
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
Sponsors
Auspex Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is at least 18 years of age or the age of majority (whichever is older) at Screening. * Participant has been diagnosed with manifest HD, as indicated by characteristic motor exam features, and has a documented expanded cytosine adenine guanine (CAG) repeat (greater than or equal to \>= \[37\]) at or before Screening. * Participant meets either of the following: 1. Has successfully completed participation in the First-HD Study (SD-809-C-15) or 2. Has been receiving an Food and Drug Administration (FDA)-approved dose of tetrabenazine that has been stable for \>=8 weeks before Screening and is providing a therapeutic benefit for control of chorea. * Participant has a Total Functional Capacity (TFC) score \>=5 at Screening. * Participant is able to swallow study medication whole. * Participant has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent. * Participant has provided a Research Advance Directive. * Female participants of childbearing potential agree to use an acceptable method of contraception from screening through study completion. * The participant has a reliable caregiver who interacts with the participant on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required. * Participant is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (such as; walker, cane) are permitted during ambulation). * Has sufficient reading skills to comprehend the participant completed rating scales.
Exclusion criteria
* Participant has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline. * Participant has active suicidal ideation at Screening or Baseline. * Participant has history of suicidal behavior at Screening or Baseline. * Participant has evidence for depression at Baseline. * Participant has an unstable or serious medical illness at Screening or Baseline. * Participant has received tetrabenazine within 7 days of Baseline (Rollover participants only). * Participant has received any of the following concomitant medications within 30 days of Screening or Baseline: Antipsychotics, Metoclopramide, Monoamine oxidase inhibitors (MAOI), Levodopa or dopamine agonists, Reserpine, Amantadine, Memantine (Rollover participants only) * Switch participants may receive Memantine if on a stable, approved dose for at least 30 days * Participant has significantly impaired swallowing function at Screening or Baseline. * Participant has significantly impaired speaking at Screening or Baseline. * Participant requires treatment with drugs known to prolong the QT interval. * Participant has prolonged QT interval on 12-lead electrocardiogram (ECG) at Screening. * Participant has evidence of hepatic impairment at Screening. * Participant has evidence of significant renal impairment at Screening. * Participant has known allergy to any of the components of study medication. * Participant has participated in an investigational drug or device trial other than SD-809-C-15 within 30 days (or 5 drug half-lives) of Screening, whichever is longer. * Participant is pregnant or breast-feeding at Screening or Baseline. * Participant acknowledges present use of illicit drugs at Screening or Baseline. * Participant has a history of alcohol or substance abuse in the previous 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Baseline to follow-up visit (up to approximately 3 years 9 months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Day 1 to end of Week 8 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Day 1 to end of Week 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Week 8 to follow-up visit (up to approximately 3 years 9 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets cells at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed values at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes mean corpuscular volume at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Hematocrit levels were calculated as the ratio of the volume of red cells to the volume of whole blood. Change from baseline in hematocrit at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in hemoglobin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in alanine aminotransferase and alkaline phosphatase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in aspartate aminotransferase and lactate dehydrogenase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Baseline, Week 8 | ECG parameters included heart rate, PR interval, QRS duration, QT interval and Fridericia's corrected QT interval (QTcF). Heart rate measured by ECG at Baseline and Week 8 is reported in this outcome measure. |
| ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | Baseline, Week 8 | ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. PR interval, QRS duration, QT interval and QTcF at Baseline and Week 8 is reported in this outcome measure. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium and triglycerides at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in protein and albumin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Baseline, Week 106 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in creatinine clearance at baseline and Week 106 is reported in this outcome measure. Observed value at baseline and observed value at Week 106 were used to calculate the change from baseline value at Week 106. |
| Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bilirubin, creatinine, direct bilirubin, and urate at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. |
| Change From Baseline in Blood Pressure at Week 171 | Baseline, Week 171 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. |
| Duration of Time to Achieve a Stable Dose of SD-809 ER | From Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8 (up to maximum 1284 days) | Duration of time to achieve stable dose of SD-809, defined as the number of days from Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8. |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171 | Baseline, Week 171 | The UPDRS is a comprehensive instrument used to assess the signs and symptoms of Parkinson's disease and includes patient and clinician-based assessments of motor, cognitive, and behavioral symptoms. The UPDRS-Dysarthria question pertaining to speech/dysarthria was used to monitor study participants for parkinsonism. Participants rated their responses on a scale ranging from 0 to 4, where 0 = normal; 1 = mildly affected, no difficulty being understood; 2 = moderately affected, sometimes asked to repeat statements; 3 = severely affected, frequently asked to repeat statements; 4 = unintelligible most of the time. Higher scores indicated greater impairment. |
| Change From Baseline in Heart Rate at Week 171 | Baseline, Week 171 | Heart rate was assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171 | Baseline, Week 171 | BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures \[self-awareness and distress\]) and a global clinical assessment. Global clinical assessment rated on a scale ranging from 0 to 5, where 0=Absent. No evidence of awareness of restlessness; 1=Questionable. Non-specific inner tension and fidgety movements; 2=Mild akathisia. Awareness of restlessness in legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements not necessarily observed; 3=Moderate akathisia. Awareness of restlessness combined with characteristic restless movements; 4=Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace; 5=Severe akathisia. Strong compulsion to pace up and down most of the time. Constant restlessness associated with intense distress and insomnia. Higher scores indicated more akathisia. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171 | Baseline, Week 171 | HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171 | Baseline, Week 171 | HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms. |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171 | Baseline, Week 171 | ESS is a self-administered questionnaire comprised of 8 questions that provides a measure of a participant's general level of daytime sleepiness. Participants were asked to rate their usual chances of dozing off or falling asleep in different situations or activities that most people engage in as part of their daily lives (sitting and reading; watching TV; sitting inactive in a public place; as a passenger in a car for an hour without a break; lying down to rest in the afternoon when circumstances permit; sitting and talking to someone; sitting quietly after a lunch without alcohol; in a car, while stopped for a few minutes in traffic), on a 4-point Likert scale ranging from 0 to 3, where 0=no chance; 1=slight chance; 2=moderate chance; 3=high chance. Total ESS score is the sum of 8 item-scores and can range between 0 and 24 with a higher the score indicating a higher level of daytime sleepiness. |
| Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to 1-week follow-up visit (up to approximately 3 years 9 months) | C-SSRS is a clinician rated assessment of suicidal behavior and ideation categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior was reported. |
| Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171 | Baseline, Week 171 | MoCA is a validated rapid screening instrument for assessing mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation by using 30 questions test. Time to administer the MoCA© is approximately 10 minutes. The total possible score ranges from 0 (worst) to 30 (best) points; where higher scores indicate better cognitive function. A score of 26 or above is considered normal and a score below 26 is considered as recognitive dysfunction. |
| Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171 | Baseline, Week 171 | The UHDRS is a research tool developed by the Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. The total behavior score is made up of subscores evaluating depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations. For each subscore the frequency and severity was assessed separately. Frequency was rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity was rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment). Higher scores indicated greater behavioral impairments. |
| Change From Baseline in UHDRS Functional Assessment Score at Week 28 | Baseline, Week 28 | The UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Functional assessment included 25 questions with possible answers 'yes' or 'no'. Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability. |
| Change From Baseline in UHDRS Independence Scale Score at Week 28 | Baseline, Week 28 | UHDRS: research tool to provide a uniform assessment of clinical features and course of HD. Components of UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Independence scale ranges from 10-100, indicating most accurate current level of participant's independence. 10=Tube fed, total bed care; 20=No speech, must be fed; 30=Participant provides minimal assistance in own feeding,bathing,toileting; 40=Chronic care facility needed; limited self-feeding; 50=24-hour supervision appropriate; assistance required for bathing,eating,toileting; 60=Needs minor assistance in dressing,toileting,bathing; 70=Self-care maintained for bathing,limited household duties; unable to manage finances; 80=Pre-disease level of employment changes or ends; cannot perform household chores, may need help with finances; 90=No physical care needed(difficult tasks avoided); 100=No special care needed. Higher scores indicate better independence. |
| Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132 | Baseline, Week 132 | UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities (TFC). TFC is a 5-item clinician rating scale typically completed after a brief interview with a participant and/or collateral source. TFC globally assesses occupation, finances, domestic chores, activities of daily living, and level of care, with scores on each item ranging from 0 to either 2 or 3 (e.g., Occupation: 0 = unable, 1 = marginal work only, 2 = reduced capacity for usual job, 3 = normal). The five items are summed to yield a TFC total score, which ranges from 0 (normal function) to 13 (severe dysfunction). Higher scores indicated better functioning. |
| Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | Baseline, Week 171 | Components of UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale, total functional capacities. Cognitive assessment component:verbal fluency(VF) score (memory,attention)(requiring participant to generate as many words as possible beginning with a specific letter\[F,A,S\]in 60 seconds \[sec\]. Score\[no range\]:total number of correct words for 3 letters), symbol digit modalities test(SDMT) score(psychomotor speed,attention)(participant is required to pair digits to assigned symbols using a reference key. Score\[0 {worst}-120 {best}\]:total number of correct written responses in 90 sec), & Stroop interference(SI) score (selective attention,executive function)(includes 3 conditions:naming colour blocks\[blue, red or green\]; reading colour words printed in black ink; naming ink colour of incongruous colour words. For each condition score(no range)is number of correct responses produced in 45 sec). In these tests, higher scores reflect better cognitive ability. |
| Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171 | Baseline, Week 171 | UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes total motor score (TMS) and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0 (absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea. |
| Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171 | Week 8, Week 171 | UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of clinical features and course of HD. Components of full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0(absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea. Data was measured and available for total safety population. Data was not available by individual cohorts (rollover cohort and switch cohort) from Week 8 to Week 171, as was done for change from baseline. Therefore, in order to present results data for this outcome measure, the total, combined safety population treatment arm was used. |
| Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171 | Baseline, Week 171 | UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function. |
| Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171 | Week 8, Week 171 | Components of full UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale,total functional capacities. Motor function assessment includes TMS and TMC score. TMS assesses all motor features of HD and includes maximal chorea, maximal dystonia,ocular pursuit,saccade initiation and velocity,dysarthria,tongue protrusion,finger tapping,hand pronation and supination,luria rigidity,bradykinesia,gait,tandem walking,retropulsion pull test. Each of these was rated on a scale of 0(normal motor function) to 4(severely impaired motor function). TMS score is a sum of individual scores ranging from 0(normal motor function) to 124(severely impaired motor function). Lower TMS scores= better motor function. Data was available for total safety population, not by individual cohorts(rollover and switch cohort) from Week 8 to Week 171,as was done for change from baseline. Therefore, in order to present results data,the total,combined safety population treatment arm was used. |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171 | Baseline, Week 171 | BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures \[self-awareness and distress\]) and a global clinical assessment. Objective akathisia rated on a scale of 0-3 (0=normal, occasional fidgety movements of limbs; 1=characteristic restless movements for less than half the time observed; 2= characteristic restless movements for at least half the time observed; 3=constant characteristic restless movements). Subjective measures included awareness of restlessness (rated on a scale of 0 \[absence of inner restlessness\] to 3 \[awareness of intense compulsion to move\]) and distress related to restlessness (rated on a scale of 0 \[no distress\] to 3 \[severe distress\]). Objective akathisia and subjective measures summed to yield summary score ranging from 0 (no akathisia and restlessness) to 9 (severe akathisia and restlessness), where higher scores indicated more akathisia and restlessness. |
| Change From Baseline in Respiration Rate at Week 171 | Baseline, Week 171 | Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. |
| Change From Baseline in Body Temperature at Week 171 | Baseline, Week 171 | Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. |
| Number of Participants With Clinically Significant Abnormalities in ECG Parameters | Baseline, Week 8 | ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. Clinical significance was as as per Investigator's discretion. |
Countries
Australia, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rollover Cohort: SD-809 ER Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. | 82 |
| Switch Cohort: SD-809 ER Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. | 37 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 1 |
| Overall Study | Caregiver can no longer participate | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance with study drug dosing | 1 | 1 |
| Overall Study | Other than specified | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Require drug that interfere with study | 1 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 1 |
| Overall Study | Withdrawal per Investigator's judgement | 1 | 1 |
Baseline characteristics
| Characteristic | Rollover Cohort: SD-809 ER | Switch Cohort: SD-809 ER | Total |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 12.27 | 52.4 years STANDARD_DEVIATION 11.48 | 53.3 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 35 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 76 Participants | 36 Participants | 112 Participants |
| Sex: Female, Male Female | 37 Participants | 15 Participants | 52 Participants |
| Sex: Female, Male Male | 45 Participants | 22 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 82 | 0 / 37 |
| other Total, other adverse events | 74 / 82 | 32 / 37 |
| serious Total, serious adverse events | 21 / 82 | 11 / 37 |
Outcome results
Primary
Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 8 to follow-up visit (up to approximately 3 years 9 months)
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Serious TEAEs | 20 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Drug-Related TEAEs | 49 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Severe TEAEs | 17 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | TEAEs Leading to Withdrawal From Study | 13 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Any TEAEs | 74 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | TEAEs Leading to Withdrawal From Study | 3 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Any TEAEs | 35 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Serious TEAEs | 10 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Severe TEAEs | 7 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Drug-Related TEAEs | 22 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline to follow-up visit (up to approximately 3 years 9 months)
Population: Safety population included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Severe TEAEs | 17 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Drug-Related TEAEs | 56 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Serious TEAEs | 21 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | TEAEs Leading to Withdrawal From Study | 13 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Any TEAEs | 77 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | TEAEs Leading to Withdrawal From Study | 3 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Any TEAEs | 35 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Serious TEAEs | 11 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Drug-Related TEAEs | 26 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Severe TEAEs | 7 Participants |
Primary
Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Day 1 to end of Week 8
Population: Safety population included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Any TEAEs | 49 Participants |
| Rollover Cohort: SD-809 ER | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Serious TEAEs | 1 Participants |
| Rollover Cohort: SD-809 ER | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Severe TEAEs | 0 Participants |
| Rollover Cohort: SD-809 ER | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Drug-Related TEAEs | 23 Participants |
| Rollover Cohort: SD-809 ER | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | TEAEs Leading to Withdrawal From Study | 0 Participants |
Primary
Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Day 1 to end of Week 4
Population: Safety population included all participants received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Any TEAEs | 17 Participants |
| Rollover Cohort: SD-809 ER | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Serious TEAEs | 1 Participants |
| Rollover Cohort: SD-809 ER | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Severe TEAEs | 1 Participants |
| Rollover Cohort: SD-809 ER | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Drug-Related TEAEs | 11 Participants |
| Rollover Cohort: SD-809 ER | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | TEAEs Leading to Withdrawal From Study | 0 Participants |
Secondary
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171
BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures \[self-awareness and distress\]) and a global clinical assessment. Global clinical assessment rated on a scale ranging from 0 to 5, where 0=Absent. No evidence of awareness of restlessness; 1=Questionable. Non-specific inner tension and fidgety movements; 2=Mild akathisia. Awareness of restlessness in legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements not necessarily observed; 3=Moderate akathisia. Awareness of restlessness combined with characteristic restless movements; 4=Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace; 5=Severe akathisia. Strong compulsion to pace up and down most of the time. Constant restlessness associated with intense distress and insomnia. Higher scores indicated more akathisia.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171 | Change at Week 171 | 0.4 units on a scale | Standard Deviation 0.79 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171 | Baseline | 0.5 units on a scale | Standard Deviation 0.83 |
| Switch Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171 | Baseline | 0.4 units on a scale | Standard Deviation 0.68 |
| Switch Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171 | Change at Week 171 | 1.0 units on a scale | Standard Deviation 1.41 |
Secondary
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171
BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures \[self-awareness and distress\]) and a global clinical assessment. Objective akathisia rated on a scale of 0-3 (0=normal, occasional fidgety movements of limbs; 1=characteristic restless movements for less than half the time observed; 2= characteristic restless movements for at least half the time observed; 3=constant characteristic restless movements). Subjective measures included awareness of restlessness (rated on a scale of 0 \[absence of inner restlessness\] to 3 \[awareness of intense compulsion to move\]) and distress related to restlessness (rated on a scale of 0 \[no distress\] to 3 \[severe distress\]). Objective akathisia and subjective measures summed to yield summary score ranging from 0 (no akathisia and restlessness) to 9 (severe akathisia and restlessness), where higher scores indicated more akathisia and restlessness.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171 | Baseline | 1.1 units on a scale | Standard Deviation 1.67 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171 | Change at Week 171 | 0.7 units on a scale | Standard Deviation 1.5 |
| Switch Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171 | Baseline | 0.8 units on a scale | Standard Deviation 1.25 |
| Switch Cohort: SD-809 ER | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171 | Change at Week 171 | 0.5 units on a scale | Standard Deviation 3.54 |
Secondary
Change From Baseline in Blood Pressure at Week 171
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | SBP: Baseline | 120.5 millimeters of mercury (mmHg) | Standard Deviation 12.7 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | SBP: Change at Week 171 | -4.0 millimeters of mercury (mmHg) | — |
| Rollover Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | DBP: Baseline | 73.3 millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | DBP: Change at Week 171 | -6.0 millimeters of mercury (mmHg) | — |
| Switch Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | SBP: Baseline | 118.9 millimeters of mercury (mmHg) | Standard Deviation 17.8 |
| Switch Cohort: SD-809 ER | Change From Baseline in Blood Pressure at Week 171 | DBP: Baseline | 73.8 millimeters of mercury (mmHg) | Standard Deviation 11.85 |
Secondary
Change From Baseline in Body Temperature at Week 171
Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Body Temperature at Week 171 | Baseline | 36.56 degrees centigrade | Standard Deviation 0.427 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Body Temperature at Week 171 | Change at Week 171 | -0.13 degrees centigrade | Standard Deviation 0.468 |
| Switch Cohort: SD-809 ER | Change From Baseline in Body Temperature at Week 171 | Baseline | 36.67 degrees centigrade | Standard Deviation 0.309 |
| Switch Cohort: SD-809 ER | Change From Baseline in Body Temperature at Week 171 | Change at Week 171 | -0.10 degrees centigrade | Standard Deviation 0.283 |
Secondary
Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158
Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Baseline | 4.60 10^12 cells per liter | Standard Deviation 0.397 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Change at Week 158 | 0.18 10^12 cells per liter | Standard Deviation 0.262 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Baseline | 4.54 10^12 cells per liter | Standard Deviation 0.377 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Change at Week 158 | 0.19 10^12 cells per liter | Standard Deviation 0.247 |
Secondary
Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158
Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes mean corpuscular volume at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Baseline | 91.1 femtoliter (fL) | Standard Deviation 3.95 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Change at Week 158 | 2.2 femtoliter (fL) | Standard Deviation 3.23 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Baseline | 92.1 femtoliter (fL) | Standard Deviation 5.39 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Change at Week 158 | 1.6 femtoliter (fL) | Standard Deviation 4.14 |
Secondary
Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158
Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Hematocrit levels were calculated as the ratio of the volume of red cells to the volume of whole blood. Change from baseline in hematocrit at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Baseline | 0.419 ratio | Standard Deviation 0.0363 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Change at Week 158 | 0.025 ratio | Standard Deviation 0.0255 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Baseline | 0.417 ratio | Standard Deviation 0.0397 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Change at Week 158 | 0.025 ratio | Standard Deviation 0.0334 |
Secondary
Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158
Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in hemoglobin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Baseline | 139.7 grams per liter (g/L) | Standard Deviation 12.26 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Change at Week 158 | 4.6 grams per liter (g/L) | Standard Deviation 7.99 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Baseline | 138.4 grams per liter (g/L) | Standard Deviation 13.19 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Change at Week 158 | 4.5 grams per liter (g/L) | Standard Deviation 11.99 |
Secondary
Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158
Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets cells at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed values at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Eosinophils: Change at Week 158 | -0.054 10^9 cells per liter | Standard Deviation 0.0784 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Lymphocytes: Change at Week 158 | -0.088 10^9 cells per liter | Standard Deviation 0.4261 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Basophils: Baseline | 0.029 10^9 cells per liter | Standard Deviation 0.0231 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Monocytes: Baseline | 0.445 10^9 cells per liter | Standard Deviation 0.1805 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Monocytes: Change at Week 158 | -0.129 10^9 cells per liter | Standard Deviation 0.1722 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Leukocytes: Baseline | 6.98 10^9 cells per liter | Standard Deviation 2.083 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Neutrophils: Baseline | 4.437 10^9 cells per liter | Standard Deviation 1.6324 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Eosinophils: Baseline | 0.151 10^9 cells per liter | Standard Deviation 0.1274 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Neutrophils: Change at Week 158 | 0.243 10^9 cells per liter | Standard Deviation 0.6359 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Leukocytes: Change at Week 158 | -0.04 10^9 cells per liter | Standard Deviation 0.927 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Platelets: Baseline | 235.6 10^9 cells per liter | Standard Deviation 62.81 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Basophils: Change at Week 158 | -0.014 10^9 cells per liter | Standard Deviation 0.0287 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Platelets: Change at Week 158 | 1.2 10^9 cells per liter | Standard Deviation 56.09 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Lymphocytes: Baseline | 1.922 10^9 cells per liter | Standard Deviation 0.7674 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Platelets: Change at Week 158 | -12.0 10^9 cells per liter | Standard Deviation 26.59 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Basophils: Baseline | 0.035 10^9 cells per liter | Standard Deviation 0.0283 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Basophils: Change at Week 158 | -0.004 10^9 cells per liter | Standard Deviation 0.0385 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Eosinophils: Baseline | 0.195 10^9 cells per liter | Standard Deviation 0.1366 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Eosinophils: Change at Week 158 | 0.009 10^9 cells per liter | Standard Deviation 0.0911 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Leukocytes: Baseline | 6.97 10^9 cells per liter | Standard Deviation 1.828 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Leukocytes: Change at Week 158 | -0.04 10^9 cells per liter | Standard Deviation 1.098 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Lymphocytes: Baseline | 1.789 10^9 cells per liter | Standard Deviation 0.7088 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Lymphocytes: Change at Week 158 | 0.075 10^9 cells per liter | Standard Deviation 0.5409 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Monocytes: Change at Week 158 | -0.068 10^9 cells per liter | Standard Deviation 0.1335 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Neutrophils: Baseline | 4.538 10^9 cells per liter | Standard Deviation 1.4741 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Neutrophils: Change at Week 158 | -0.050 10^9 cells per liter | Standard Deviation 0.8166 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Platelets: Baseline | 247.2 10^9 cells per liter | Standard Deviation 77.63 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Monocytes: Baseline | 0.416 10^9 cells per liter | Standard Deviation 0.1416 |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in creatinine clearance at baseline and Week 106 is reported in this outcome measure. Observed value at baseline and observed value at Week 106 were used to calculate the change from baseline value at Week 106.
Time frame: Baseline, Week 106
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Baseline | 94.1 milliliters per minute (mL/min) | Standard Deviation 26.67 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Change at Week 106 | -4.5 milliliters per minute (mL/min) | Standard Deviation 6.36 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Baseline | 89.9 milliliters per minute (mL/min) | Standard Deviation 27.55 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Change at Week 106 | -34.0 milliliters per minute (mL/min) | — |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in alanine aminotransferase and alkaline phosphatase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alanine Aminotransferase: Baseline | 20.7 international units per liter (IU/L) | Standard Deviation 9.74 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alanine Aminotransferase: Change at Week 158 | -5.3 international units per liter (IU/L) | Standard Deviation 7.51 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alkaline Phosphatase: Baseline | 72.6 international units per liter (IU/L) | Standard Deviation 20.24 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alkaline Phosphatase: Change at Week 158 | -1.0 international units per liter (IU/L) | Standard Deviation 8.21 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alkaline Phosphatase: Change at Week 158 | 1.0 international units per liter (IU/L) | Standard Deviation 9.62 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alanine Aminotransferase: Baseline | 18.9 international units per liter (IU/L) | Standard Deviation 12.2 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alkaline Phosphatase: Baseline | 73.1 international units per liter (IU/L) | Standard Deviation 20.61 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Alanine Aminotransferase: Change at Week 158 | -2.1 international units per liter (IU/L) | Standard Deviation 9.74 |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in aspartate aminotransferase and lactate dehydrogenase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Aspartate Aminotransferase: Baseline | 20.5 units per liter (U/L) | Standard Deviation 5.84 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Aspartate Aminotransferase: Change at Week 158 | -2.7 units per liter (U/L) | Standard Deviation 5.43 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Lactate Dehydrogenase: Baseline | 163.9 units per liter (U/L) | Standard Deviation 28.05 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Lactate Dehydrogenase: Change at Week 158 | -5.5 units per liter (U/L) | Standard Deviation 27.83 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Lactate Dehydrogenase: Change at Week 158 | -4.9 units per liter (U/L) | Standard Deviation 18.45 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Aspartate Aminotransferase: Baseline | 18.4 units per liter (U/L) | Standard Deviation 6.88 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Lactate Dehydrogenase: Baseline | 161.1 units per liter (U/L) | Standard Deviation 42.32 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Aspartate Aminotransferase: Change at Week 158 | -1.1 units per liter (U/L) | Standard Deviation 5.4 |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium and triglycerides at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Glucose: Baseline | 5.28 millimoles per liter (mmol/L) | Standard Deviation 1.571 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Calcium: Baseline | 2.417 millimoles per liter (mmol/L) | Standard Deviation 0.1067 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Glucose: Change at Week 158 | -0.54 millimoles per liter (mmol/L) | Standard Deviation 1.018 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Bicarbonate: Baseline | 24.7 millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Magnesium: Baseline | 0.871 millimoles per liter (mmol/L) | Standard Deviation 0.0566 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Calcium: Change at Week 158 | -0.034 millimoles per liter (mmol/L) | Standard Deviation 0.1282 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Magnesium: Change at Week 158 | -0.027 millimoles per liter (mmol/L) | Standard Deviation 0.0701 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Blood Urea Nitrogen: Baseline | 5.979 millimoles per liter (mmol/L) | Standard Deviation 1.8432 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Phosphate: Baseline | 1.194 millimoles per liter (mmol/L) | Standard Deviation 0.1769 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Chloride: Baseline | 102.5 millimoles per liter (mmol/L) | Standard Deviation 2.28 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Phosphate: Change at Week 158 | -0.029 millimoles per liter (mmol/L) | Standard Deviation 0.2298 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Sodium: Change at Week 158 | -2.0 millimoles per liter (mmol/L) | Standard Deviation 3.56 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Potassium: Baseline | 4.39 millimoles per liter (mmol/L) | Standard Deviation 0.419 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Chloride: Change at Week 158 | -2.7 millimoles per liter (mmol/L) | Standard Deviation 2.62 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Potassium: Change at Week 158 | -0.14 millimoles per liter (mmol/L) | Standard Deviation 0.414 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Sodium: Baseline | 142.4 millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Cholesterol: Baseline | 5.118 millimoles per liter (mmol/L) | Standard Deviation 0.9505 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Blood Urea Nitrogen: Change at Week 158 | -0.531 millimoles per liter (mmol/L) | Standard Deviation 1.4864 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Triglycerides: Baseline | 1.606 millimoles per liter (mmol/L) | Standard Deviation 1.0001 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Cholesterol: Change at Week 158 | -0.131 millimoles per liter (mmol/L) | Standard Deviation 0.879 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Triglycerides: Change at Week 158 | -0.147 millimoles per liter (mmol/L) | Standard Deviation 0.8692 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Bicarbonate: Change at Week 158 | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Triglycerides: Change at Week 158 | -0.420 millimoles per liter (mmol/L) | Standard Deviation 1.0005 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Potassium: Change at Week 158 | 0.19 millimoles per liter (mmol/L) | Standard Deviation 0.501 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Bicarbonate: Baseline | 24.7 millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Bicarbonate: Change at Week 158 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 3.16 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Blood Urea Nitrogen: Baseline | 6.282 millimoles per liter (mmol/L) | Standard Deviation 1.8177 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Blood Urea Nitrogen: Change at Week 158 | -0.323 millimoles per liter (mmol/L) | Standard Deviation 0.9797 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Calcium: Baseline | 2.393 millimoles per liter (mmol/L) | Standard Deviation 0.1523 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Calcium: Change at Week 158 | -0.067 millimoles per liter (mmol/L) | Standard Deviation 0.0869 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Chloride: Baseline | 103.8 millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Cholesterol: Baseline | 4.863 millimoles per liter (mmol/L) | Standard Deviation 1.1686 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Cholesterol: Change at Week 158 | -0.173 millimoles per liter (mmol/L) | Standard Deviation 0.7715 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Glucose: Baseline | 5.31 millimoles per liter (mmol/L) | Standard Deviation 1.029 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Glucose: Change at Week 158 | -0.64 millimoles per liter (mmol/L) | Standard Deviation 1.033 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Magnesium: Baseline | 0.843 millimoles per liter (mmol/L) | Standard Deviation 0.0567 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Magnesium: Change at Week 158 | 0.016 millimoles per liter (mmol/L) | Standard Deviation 0.0639 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Phosphate: Baseline | 1.191 millimoles per liter (mmol/L) | Standard Deviation 0.1661 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Phosphate: Change at Week 158 | 0.061 millimoles per liter (mmol/L) | Standard Deviation 0.133 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Potassium: Baseline | 4.46 millimoles per liter (mmol/L) | Standard Deviation 0.332 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Sodium: Baseline | 142.9 millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Sodium: Change at Week 158 | -1.7 millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Triglycerides: Baseline | 1.733 millimoles per liter (mmol/L) | Standard Deviation 1.2887 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Chloride: Change at Week 158 | -2.0 millimoles per liter (mmol/L) | Standard Deviation 1.5 |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bilirubin, creatinine, direct bilirubin, and urate at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Direct Bilirubin: Baseline | 2.4 micromoles per liter | Standard Deviation 0.94 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Direct Bilirubin: Change at Week 158 | 0.1 micromoles per liter | Standard Deviation 0.23 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Urate: Baseline | 305.2 micromoles per liter | Standard Deviation 83.7 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Urate: Change at Week 158 | -21.8 micromoles per liter | Standard Deviation 55.5 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Bilirubin: Baseline | 7.8 micromoles per liter | Standard Deviation 4.82 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Bilirubin: Change at Week 158 | -0.7 micromoles per liter | Standard Deviation 2.51 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Creatinine: Baseline | 82.8 micromoles per liter | Standard Deviation 16.81 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Creatinine: Change at Week 158 | -2.4 micromoles per liter | Standard Deviation 10.13 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Creatinine: Baseline | 84.2 micromoles per liter | Standard Deviation 19.02 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Creatinine: Change at Week 158 | -2.4 micromoles per liter | Standard Deviation 6.46 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Urate: Change at Week 158 | -3.4 micromoles per liter | Standard Deviation 39.37 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Direct Bilirubin: Baseline | 2.1 micromoles per liter | Standard Deviation 0.35 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Bilirubin: Change at Week 158 | -1.4 micromoles per liter | Standard Deviation 2.07 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Direct Bilirubin: Change at Week 158 | -0.2 micromoles per liter | Standard Deviation 0.44 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Bilirubin: Baseline | 6.0 micromoles per liter | Standard Deviation 2.43 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Urate: Baseline | 269.5 micromoles per liter | Standard Deviation 75.06 |
Secondary
Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158
Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in protein and albumin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time frame: Baseline, Week 158
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Protein: Baseline | 69.5 g/L | Standard Deviation 3.88 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Albumin: Baseline | 43.9 g/L | Standard Deviation 2.55 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Protein: Change at Week 158 | -0.9 g/L | Standard Deviation 3.54 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Albumin: Change at Week 158 | 0.2 g/L | Standard Deviation 3.61 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Albumin: Change at Week 158 | -0.9 g/L | Standard Deviation 2.57 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Protein: Baseline | 67.3 g/L | Standard Deviation 4.54 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Protein: Change at Week 158 | -2.9 g/L | Standard Deviation 4.43 |
| Switch Cohort: SD-809 ER | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Albumin: Baseline | 43.1 g/L | Standard Deviation 2.65 |
Secondary
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171
ESS is a self-administered questionnaire comprised of 8 questions that provides a measure of a participant's general level of daytime sleepiness. Participants were asked to rate their usual chances of dozing off or falling asleep in different situations or activities that most people engage in as part of their daily lives (sitting and reading; watching TV; sitting inactive in a public place; as a passenger in a car for an hour without a break; lying down to rest in the afternoon when circumstances permit; sitting and talking to someone; sitting quietly after a lunch without alcohol; in a car, while stopped for a few minutes in traffic), on a 4-point Likert scale ranging from 0 to 3, where 0=no chance; 1=slight chance; 2=moderate chance; 3=high chance. Total ESS score is the sum of 8 item-scores and can range between 0 and 24 with a higher the score indicating a higher level of daytime sleepiness.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171 | Baseline | 4.4 units on a scale | Standard Deviation 3.72 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171 | Change at Week 171 | 4.7 units on a scale | Standard Deviation 7.45 |
| Switch Cohort: SD-809 ER | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171 | Baseline | 6.0 units on a scale | Standard Deviation 4.15 |
| Switch Cohort: SD-809 ER | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171 | Change at Week 171 | 1.0 units on a scale | Standard Deviation 1.41 |
Secondary
Change From Baseline in Heart Rate at Week 171
Heart rate was assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Heart Rate at Week 171 | Baseline | 70.7 beats per minute | Standard Deviation 8.68 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Heart Rate at Week 171 | Change at Week 171 | 25.0 beats per minute | — |
| Switch Cohort: SD-809 ER | Change From Baseline in Heart Rate at Week 171 | Baseline | 68.1 beats per minute | Standard Deviation 12.56 |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171
HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171 | Baseline | 2.7 units on a scale | Standard Deviation 2.99 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171 | Change at Week 171 | 1.3 units on a scale | Standard Deviation 2.63 |
| Switch Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171 | Baseline | 4.3 units on a scale | Standard Deviation 3.45 |
| Switch Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171 | Change at Week 171 | -2.5 units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171
HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171 | Baseline | 2.0 units on a scale | Standard Deviation 2.47 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171 | Change at Week 171 | 2.4 units on a scale | Standard Deviation 5.26 |
| Switch Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171 | Baseline | 3.4 units on a scale | Standard Deviation 2.54 |
| Switch Cohort: SD-809 ER | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171 | Change at Week 171 | 2.0 units on a scale | Standard Deviation 4.24 |
Secondary
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171
MoCA is a validated rapid screening instrument for assessing mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation by using 30 questions test. Time to administer the MoCA© is approximately 10 minutes. The total possible score ranges from 0 (worst) to 30 (best) points; where higher scores indicate better cognitive function. A score of 26 or above is considered normal and a score below 26 is considered as recognitive dysfunction.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171 | Baseline | 23.9 units on a scale | Standard Deviation 4.35 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171 | Change at Week 171 | -3.1 units on a scale | Standard Deviation 4.81 |
| Switch Cohort: SD-809 ER | Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171 | Baseline | 21.9 units on a scale | Standard Deviation 3.86 |
| Switch Cohort: SD-809 ER | Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171 | Change at Week 171 | 4.5 units on a scale | Standard Deviation 3.54 |
Secondary
Change From Baseline in Respiration Rate at Week 171
Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Respiration Rate at Week 171 | Baseline | 16.4 breaths/minute | Standard Deviation 2.57 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Respiration Rate at Week 171 | Change at Week 171 | -1.3 breaths/minute | Standard Deviation 2.06 |
| Switch Cohort: SD-809 ER | Change From Baseline in Respiration Rate at Week 171 | Baseline | 17.5 breaths/minute | Standard Deviation 2.58 |
| Switch Cohort: SD-809 ER | Change From Baseline in Respiration Rate at Week 171 | Change at Week 171 | -3.5 breaths/minute | Standard Deviation 3.54 |
Secondary
Change From Baseline in UHDRS Cognitive Assessment Score at Week 171
Components of UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale, total functional capacities. Cognitive assessment component:verbal fluency(VF) score (memory,attention)(requiring participant to generate as many words as possible beginning with a specific letter\[F,A,S\]in 60 seconds \[sec\]. Score\[no range\]:total number of correct words for 3 letters), symbol digit modalities test(SDMT) score(psychomotor speed,attention)(participant is required to pair digits to assigned symbols using a reference key. Score\[0 {worst}-120 {best}\]:total number of correct written responses in 90 sec), & Stroop interference(SI) score (selective attention,executive function)(includes 3 conditions:naming colour blocks\[blue, red or green\]; reading colour words printed in black ink; naming ink colour of incongruous colour words. For each condition score(no range)is number of correct responses produced in 45 sec). In these tests, higher scores reflect better cognitive ability.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | VF Score: Baseline | 25.1 units on a scale | Standard Deviation 11 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | VF Score: Change at Week 171 | -10.9 units on a scale | Standard Deviation 10.12 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SDMT: Baseline | 24.4 units on a scale | Standard Deviation 8.91 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SDMT: Change at Week 171 | -9.6 units on a scale | Standard Deviation 7.04 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SI Score: Baseline | 3.2 units on a scale | Standard Deviation 10.87 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SI Score: Change at Week 171 | -2.4 units on a scale | Standard Deviation 7.42 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SI Score: Baseline | -0.5 units on a scale | Standard Deviation 6.38 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | VF Score: Baseline | 21.5 units on a scale | Standard Deviation 10.79 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SDMT: Change at Week 171 | 0.0 units on a scale | Standard Deviation 7.07 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | VF Score: Change at Week 171 | 4.0 units on a scale | Standard Deviation 5.66 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SI Score: Change at Week 171 | 6.5 units on a scale | Standard Deviation 4.27 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Cognitive Assessment Score at Week 171 | SDMT: Baseline | 22.7 units on a scale | Standard Deviation 17.38 |
Secondary
Change From Baseline in UHDRS Functional Assessment Score at Week 28
The UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Functional assessment included 25 questions with possible answers 'yes' or 'no'. Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability.
Time frame: Baseline, Week 28
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Functional Assessment Score at Week 28 | Baseline | 21.4 units on a scale | Standard Deviation 3 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Functional Assessment Score at Week 28 | Change at Week 28 | -1.6 units on a scale | Standard Deviation 2.76 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Functional Assessment Score at Week 28 | Baseline | 18.2 units on a scale | Standard Deviation 4.94 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Functional Assessment Score at Week 28 | Change at Week 28 | -1.6 units on a scale | Standard Deviation 3.62 |
Secondary
Change From Baseline in UHDRS Independence Scale Score at Week 28
UHDRS: research tool to provide a uniform assessment of clinical features and course of HD. Components of UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Independence scale ranges from 10-100, indicating most accurate current level of participant's independence. 10=Tube fed, total bed care; 20=No speech, must be fed; 30=Participant provides minimal assistance in own feeding,bathing,toileting; 40=Chronic care facility needed; limited self-feeding; 50=24-hour supervision appropriate; assistance required for bathing,eating,toileting; 60=Needs minor assistance in dressing,toileting,bathing; 70=Self-care maintained for bathing,limited household duties; unable to manage finances; 80=Pre-disease level of employment changes or ends; cannot perform household chores, may need help with finances; 90=No physical care needed(difficult tasks avoided); 100=No special care needed. Higher scores indicate better independence.
Time frame: Baseline, Week 28
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Independence Scale Score at Week 28 | Baseline | 84.0 units on a scale | Standard Deviation 9.48 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Independence Scale Score at Week 28 | Change at Week 28 | -4.2 units on a scale | Standard Deviation 9.6 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Independence Scale Score at Week 28 | Baseline | 75.5 units on a scale | Standard Deviation 11.59 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Independence Scale Score at Week 28 | Change at Week 28 | -1.2 units on a scale | Standard Deviation 8.93 |
Secondary
Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171
UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes total motor score (TMS) and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0 (absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171 | Baseline | 12.04 units on a scale | Standard Deviation 4.113 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171 | Change at Week 171 | -3.71 units on a scale | Standard Deviation 7.544 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171 | Baseline | 12.46 units on a scale | Standard Deviation 5.221 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171 | Change at Week 171 | 4.75 units on a scale | Standard Deviation 1.061 |
Secondary
Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171
UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171 | Baseline | 34.67 units on a scale | Standard Deviation 16.119 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171 | Change at Week 171 | 11.29 units on a scale | Standard Deviation 14.762 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171 | Baseline | 37.76 units on a scale | Standard Deviation 18.605 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171 | Change at Week 171 | 18.50 units on a scale | Standard Deviation 3.536 |
Secondary
Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132
UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities (TFC). TFC is a 5-item clinician rating scale typically completed after a brief interview with a participant and/or collateral source. TFC globally assesses occupation, finances, domestic chores, activities of daily living, and level of care, with scores on each item ranging from 0 to either 2 or 3 (e.g., Occupation: 0 = unable, 1 = marginal work only, 2 = reduced capacity for usual job, 3 = normal). The five items are summed to yield a TFC total score, which ranges from 0 (normal function) to 13 (severe dysfunction). Higher scores indicated better functioning.
Time frame: Baseline, Week 132
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132 | Baseline | 9.6 units on a scale | Standard Deviation 2.17 |
| Rollover Cohort: SD-809 ER | Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132 | Change at Week 132 | -3.1 units on a scale | Standard Deviation 2.86 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132 | Baseline | 8.3 units on a scale | Standard Deviation 2.11 |
| Switch Cohort: SD-809 ER | Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132 | Change at Week 132 | -3.1 units on a scale | Standard Deviation 2.71 |
Secondary
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171
The UHDRS is a research tool developed by the Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. The total behavior score is made up of subscores evaluating depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations. For each subscore the frequency and severity was assessed separately. Frequency was rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity was rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment). Higher scores indicated greater behavioral impairments.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171 | Baseline | 7.1 units on a scale | Standard Deviation 8.26 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171 | Change at Week 171 | 8.6 units on a scale | Standard Deviation 12.47 |
| Switch Cohort: SD-809 ER | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171 | Baseline | 10.9 units on a scale | Standard Deviation 10.66 |
| Switch Cohort: SD-809 ER | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171 | Change at Week 171 | 4.5 units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171
The UPDRS is a comprehensive instrument used to assess the signs and symptoms of Parkinson's disease and includes patient and clinician-based assessments of motor, cognitive, and behavioral symptoms. The UPDRS-Dysarthria question pertaining to speech/dysarthria was used to monitor study participants for parkinsonism. Participants rated their responses on a scale ranging from 0 to 4, where 0 = normal; 1 = mildly affected, no difficulty being understood; 2 = moderately affected, sometimes asked to repeat statements; 3 = severely affected, frequently asked to repeat statements; 4 = unintelligible most of the time. Higher scores indicated greater impairment.
Time frame: Baseline, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171 | Baseline | 0.9 units on a scale | Standard Deviation 0.79 |
| Rollover Cohort: SD-809 ER | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171 | Change at Week 171 | 0.4 units on a scale | Standard Deviation 0.79 |
| Switch Cohort: SD-809 ER | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171 | Baseline | 1.1 units on a scale | Standard Deviation 0.74 |
| Switch Cohort: SD-809 ER | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171 | Change at Week 171 | 1.5 units on a scale | Standard Deviation 0.71 |
Secondary
Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171
UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of clinical features and course of HD. Components of full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0(absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea. Data was measured and available for total safety population. Data was not available by individual cohorts (rollover cohort and switch cohort) from Week 8 to Week 171, as was done for change from baseline. Therefore, in order to present results data for this outcome measure, the total, combined safety population treatment arm was used.
Time frame: Week 8, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171 | Change at Week 171 | 2.4 units on a scale | Standard Deviation 5 |
| Rollover Cohort: SD-809 ER | Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171 | Week 8 | 8.5 units on a scale | Standard Deviation 4.67 |
Secondary
Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171
Components of full UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale,total functional capacities. Motor function assessment includes TMS and TMC score. TMS assesses all motor features of HD and includes maximal chorea, maximal dystonia,ocular pursuit,saccade initiation and velocity,dysarthria,tongue protrusion,finger tapping,hand pronation and supination,luria rigidity,bradykinesia,gait,tandem walking,retropulsion pull test. Each of these was rated on a scale of 0(normal motor function) to 4(severely impaired motor function). TMS score is a sum of individual scores ranging from 0(normal motor function) to 124(severely impaired motor function). Lower TMS scores= better motor function. Data was available for total safety population, not by individual cohorts(rollover and switch cohort) from Week 8 to Week 171,as was done for change from baseline. Therefore, in order to present results data,the total,combined safety population treatment arm was used.
Time frame: Week 8, Week 171
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171 | Week 8 | 30.7 units on a scale | Standard Deviation 17.4 |
| Rollover Cohort: SD-809 ER | Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171 | Change at Week 171 | 22.2 units on a scale | Standard Deviation 12.02 |
Secondary
Duration of Time to Achieve a Stable Dose of SD-809 ER
Duration of time to achieve stable dose of SD-809, defined as the number of days from Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8.
Time frame: From Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8 (up to maximum 1284 days)
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rollover Cohort: SD-809 ER | Duration of Time to Achieve a Stable Dose of SD-809 ER | 47.0 days |
| Switch Cohort: SD-809 ER | Duration of Time to Achieve a Stable Dose of SD-809 ER | 28.0 days |
Secondary
ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8
ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. PR interval, QRS duration, QT interval and QTcF at Baseline and Week 8 is reported in this outcome measure.
Time frame: Baseline, Week 8
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QRS Duration: Baseline | 92.8 milliseconds | Standard Deviation 14.37 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QRS Duration: Week 8 | 91.0 milliseconds | Standard Deviation 12.09 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | PR Interval: Baseline | 164.1 milliseconds | Standard Deviation 25.03 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | PR Interval: Week 8 | 165.2 milliseconds | Standard Deviation 23.87 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QT Interval: Baseline | 399.8 milliseconds | Standard Deviation 27.44 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QT Interval: Week 8 | 405.1 milliseconds | Standard Deviation 29.1 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QTcF: Baseline | 413.3 milliseconds | Standard Deviation 18.67 |
| Rollover Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QTcF: Week 8 | 412.7 milliseconds | Standard Deviation 20.1 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QTcF: Week 8 | 412.8 milliseconds | Standard Deviation 18.05 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QRS Duration: Baseline | 88.8 milliseconds | Standard Deviation 10.16 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QT Interval: Baseline | 415.6 milliseconds | Standard Deviation 37.44 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QRS Duration: Week 8 | 88.0 milliseconds | Standard Deviation 10.97 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QTcF: Baseline | 419.3 milliseconds | Standard Deviation 17.89 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | PR Interval: Baseline | 159.5 milliseconds | Standard Deviation 22.65 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | QT Interval: Week 8 | 404.5 milliseconds | Standard Deviation 35.43 |
| Switch Cohort: SD-809 ER | ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8 | PR Interval: Week 8 | 155.7 milliseconds | Standard Deviation 18.08 |
Secondary
Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8
ECG parameters included heart rate, PR interval, QRS duration, QT interval and Fridericia's corrected QT interval (QTcF). Heart rate measured by ECG at Baseline and Week 8 is reported in this outcome measure.
Time frame: Baseline, Week 8
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover Cohort: SD-809 ER | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Baseline | 67.4 beats/minute | Standard Deviation 9.87 |
| Rollover Cohort: SD-809 ER | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Week 8 | 64.6 beats/minute | Standard Deviation 9.22 |
| Switch Cohort: SD-809 ER | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Baseline | 63.8 beats/minute | Standard Deviation 13.96 |
| Switch Cohort: SD-809 ER | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Week 8 | 65.8 beats/minute | Standard Deviation 13.5 |
Secondary
Number of Participants With Clinically Significant Abnormalities in ECG Parameters
ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. Clinical significance was as as per Investigator's discretion.
Time frame: Baseline, Week 8
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Number of Participants With Clinically Significant Abnormalities in ECG Parameters | Baseline | 5 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Clinically Significant Abnormalities in ECG Parameters | Week 8 | 2 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Clinically Significant Abnormalities in ECG Parameters | Baseline | 0 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Clinically Significant Abnormalities in ECG Parameters | Week 8 | 0 Participants |
Secondary
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and ideation categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior was reported.
Time frame: Baseline up to 1-week follow-up visit (up to approximately 3 years 9 months)
Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rollover Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 3 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 11 Participants |
| Rollover Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent | 1 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 4 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 1 Participants |
| Switch Cohort: SD-809 ER | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent | 0 Participants |