Fibromyalgia
Conditions
Keywords
ASP0819, Fibromyalgia
Brief summary
This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety and tolerability. This study assessed treatment differences in physical function as well as the improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning) of ASP0819 relative to placebo.
Interventions
DRUGASP0819
Oral capsule
DRUGPlacebo
Oral capsule
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a body mass index (BMI) ≤ 45 kg/m2. * Female subject must either: * Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy). * Or, if of childbearing potential: agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration. * Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration. * Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration * Male subject must not donate sperm starting at Screening and throughout the study period, and for 28 days after the final study drug administration. * Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 28 days after the final study drug administration. * Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening: * Widespread pain for at least 3 months, defined as the presence of all of the following: pain on right and left sides of the body, pain above and below the waist, and pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present. * Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg. * Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening: * Widespread pain index (WPI) ≥ 7 and Symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9. * Symptoms have been present at a similar level for at least 3 months. * The subject does not have a disorder that would otherwise explain the pain. * Subject has a pain score ≥ 4 on the revised fibromyalgia impact questionnaire revised (FIQR) pain item at Screening. * Subject is compliant with daily pain recordings during the Baseline Diary Run-In period, as defined by the completion of a minimum of 5 of 7 daily average pain ratings and agrees to complete daily diaries throughout the duration of the study. * Subject has a mean daily average pain score ≥ 4 and ≤ 9 on an 11-point 0 to 10 NRS as recorded in the subject e-diary during the Baseline Diary Run-In period, and meeting pre-specified criteria for daily average pain scores. * Subject agrees to use only acetaminophen as rescue medication for fibromyalgia pain throughout the course of the trial (up to 1000 mg per dose and not to exceed 3000 mg/day). * Subject agrees not to initiate or change any non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) during the course of the study. Non-pharmacologic interventions must be stable for a minimum of 30 days prior to Screening. The subject agrees to maintain usual level of activity for the duration of the study. * Subject is capable of completing study assessments and procedures. * Subject agrees not to participate in another interventional study from Screening through the End of Study (EOS) visit.
Exclusion criteria
* Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening. * Subject has had no meaningful improvement, from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes). * Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP0819. * Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation. * Subject has infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and gout), autoimmune disease (e.g., systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia. * Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening. * Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period. * Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I. * Subject has a Hospital Anxiety and Depression Scale (HADS) score \> 14 on the Depression subscale at Screening or at the time of Visit 3 (Randomization). * Subject has a history of suicide attempt or suicidal behavior within the last 12 months, or has suicidal ideation within the last 12 months (a response of yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS)), or who is at significant risk to commit suicide at the time of Visit 3 (Randomization). * Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine \> 1.5 times the Upper limit of normal (ULN) at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). * Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of the reference range at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). * Subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV \[IgM\]) or hepatitis C virus antibodies (anti-HCV) at Screening or has history of a positive test for human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2). * Subject has a resting systolic blood pressure (SBP) \> 180 mmHg or \< 90 mmHg, and/or a sitting diastolic blood pressure (DBP) \> 100 mmHg at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). * Subject has a clinically significant abnormality on 12-lead Electrocardiogram (ECG) at Screening or Visit 3 (Randomization). If the ECG is abnormal, an additional ECG can be carried out. If this also gives an abnormal result, the subject must be excluded. * Subject has a history of myocardial infarction (within 6 months of Screening), unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long time from electrocardiogram Q wave to the end of the T wave (QT) Syndrome. * Subject has evidence of any clinically significant, uncontrolled cardiovascular, gastrointestinal, endocrinologic (low thyroid stimulating hormone \[TSH\], but euthyroid is allowed), hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary (including obstructive sleep apnea not controlled by a Continuous positive airway pressure (CPAP) device) neurologic, dermatologic, psychiatric, renal and/or other major disease (exclusive of fibromyalgia). * Subject has planned surgery during the study participation. * Subject has an active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within 5 years of Screening. * Subject has a positive drug or alcohol test at Screening, Baseline Diary Run-In or prior to Randomization. However, a positive test for tetrahydrocannabinol (THC) and/or opioids is allowed at the Screening visit, but must be confirmed negative prior to Baseline Diary Run-In and Randomization. * Subject has a current or recent (within 12 months of Screening) history of a substance use disorder including cannabinoid and/or alcohol abuse disorder. Subject has used opioids for pain for more than 4 days during the week preceding the Screening visit. * Subject is currently using protocol specified prohibited medications and is unable to wash-out. * Subject has filed or is awaiting judgment on a disability claim or has any pending worker's compensation litigation or related monetary settlements. * Subject is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 | Week 10 | C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide. |
| Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | Baseline and week 8 | The change from baseline to Week 8 in mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome). |
| Number of Participants With Adverse Events | From first dose of study drug until end of study (up to Day 85) | TEAE was defined as any AE which started, or worsened, after the first dose of study drug through 30 days after the last dose of study drug. AE was considered serious if: resulted in death, was life- threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events. |
| Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 | Week 2 | C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide. |
| Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 | Week 4 | C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide. |
| Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 | Week 8 | C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Greater Than or Equal to (≥)30 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | Baseline and week 8 | The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. |
| Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS | Baseline and EOT (Up to week 8) | The mean daily average pain score is assessed by NRS.The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. |
| Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | Baseline and week 8 | The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. |
| Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS | Baseline and EOT (Up to week 8) | The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. |
| Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Baseline and weeks 2, 4, 8 | The 21-item FIQR contains 3 domains: activities of daily living, overall impact, and symptoms. Participants answer each question on an 11-point NRS, with anchors appropriate to each question. The range of function subscale scores will be 0 to 90, with a lower score indicting better (higher) function. The range of overall impact subscale scores will be 0 to 20, with a lower score indicating better (lower) impact. The range of symptoms subscale scores will be 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome). |
| Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Weeks 2, 4, and EOT (Up to week 8) | The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. PGIC score ranges from 1 to 7, where 1 anchors Very Much Improved and 7 anchors Very Much Worse. |
Countries
United States
Participant flow
Recruitment details
Male and female participants between 18 and 80 years of age with fibromyalgia were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks. | 95 |
| ASP0819 15 mg Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks. | 91 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Miscellaneous | 1 | 2 |
| Overall Study | Non-compliance with Study Drug | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Placebo | ASP0819 15 mg | Total |
|---|---|---|---|
| Age, Continuous | 49.9 Years STANDARD_DEVIATION 12.5 | 48.7 Years STANDARD_DEVIATION 12 | 49.3 Years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 10 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 81 Participants | 163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean Daily Average Pain Score | 6.32 Units on a scale STANDARD_DEVIATION 1.02 | 6.32 Units on a scale STANDARD_DEVIATION 1.01 | 6.32 Units on a scale STANDARD_DEVIATION 1.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 11 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 74 Participants | 78 Participants | 152 Participants |
| Sex: Female, Male Female | 90 Participants | 89 Participants | 179 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 90 |
| other Total, other adverse events | 27 / 94 | 30 / 90 |
| serious Total, serious adverse events | 0 / 94 | 0 / 90 |
Outcome results
Primary
Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS
The change from baseline to Week 8 in mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome).
Time frame: Baseline and week 8
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | -1.26 Units on a scale | Standard Error 0.18 |
| ASP0819 15 mg | Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | -1.60 Units on a scale | Standard Error 0.18 |
p-value: 0.08690% CI: [-0.76, 0.07]MMRM
Primary
Number of Participants With Adverse Events
TEAE was defined as any AE which started, or worsened, after the first dose of study drug through 30 days after the last dose of study drug. AE was considered serious if: resulted in death, was life- threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events.
Time frame: From first dose of study drug until end of study (up to Day 85)
Population: The safety analysis set (SAF) consisted of all randomized participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events | Treatment emergent adverse event (TEAE) | 53 Participants |
| Placebo | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
| ASP0819 15 mg | Number of Participants With Adverse Events | Treatment emergent adverse event (TEAE) | 62 Participants |
| ASP0819 15 mg | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
Primary
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10
C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.
Time frame: Week 10
Population: SAF population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 | Week 10: Suicidal Ideation | 1 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 | Week 10: Suicidal Behavior | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 | Week 10: Suicidal Ideation | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 | Week 10: Suicidal Behavior | 0 Participants |
Primary
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2
C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.
Time frame: Week 2
Population: SAF population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 | Week 2: Suicidal Behavior | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 | Week 2: Suicidal Ideation | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 | Week 2: Suicidal Ideation | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 | Week 2: Suicidal Behavior | 0 Participants |
Primary
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4
C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.
Time frame: Week 4
Population: SAF population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 | Week 4: Suicidal Ideation | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 | Week 4: Suicidal Behavior | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 | Week 4: Suicidal Ideation | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 | Week 4: Suicidal Behavior | 0 Participants |
Primary
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8
C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A yes answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: yes answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.
Time frame: Week 8
Population: SAF population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 | Week 8: Suicidal Ideation | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 | Week 8: Suicidal Behavior | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 | Week 8: Suicidal Ideation | 0 Participants |
| ASP0819 15 mg | Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 | Week 8: Suicidal Behavior | 0 Participants |
Secondary
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales
The 21-item FIQR contains 3 domains: activities of daily living, overall impact, and symptoms. Participants answer each question on an 11-point NRS, with anchors appropriate to each question. The range of function subscale scores will be 0 to 90, with a lower score indicting better (higher) function. The range of overall impact subscale scores will be 0 to 20, with a lower score indicating better (lower) impact. The range of symptoms subscale scores will be 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome).
Time frame: Baseline and EOT (Up to week 8)
Population: FAS population with LOCF Imputation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Function Subscale: EOT | -10.41 Units on a scale | Standard Error 1.66 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Symptom Subscale: EOT | -10.79 Units on a scale | Standard Error 1.52 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Overall Impact Subscale: EOT | -3.40 Units on a scale | Standard Error 0.46 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Function Subscale: EOT | -13.55 Units on a scale | Standard Error 1.7 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Symptom Subscale: EOT | -14.07 Units on a scale | Standard Error 1.56 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Overall Impact Subscale: EOT | -4.48 Units on a scale | Standard Error 0.47 |
Comparison: Function Subscalep-value: 0.09290% CI: [-7.05, 0.75]ANCOVA
Comparison: Symptoms subscalep-value: 0.06590% CI: [-6.85, 0.28]ANCOVA
Comparison: Overall Impact Subscale.p-value: 0.04990% CI: [-2.15, -0.01]ANCOVA
Secondary
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales
The 21-item FIQR contains 3 domains: activities of daily living, overall impact, and symptoms. Participants answer each question on an 11-point NRS, with anchors appropriate to each question. The range of function subscale scores will be 0 to 90, with a lower score indicting better (higher) function. The range of overall impact subscale scores will be 0 to 20, with a lower score indicating better (lower) impact. The range of symptoms subscale scores will be 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome).
Time frame: Baseline and weeks 2, 4, 8
Population: FAS population with available data at specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Function Subscale | -9.11 Units on a scale | Standard Error 1.67 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Symptom Subscale | -11.14 Units on a scale | Standard Error 1.65 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Symptom Subscale | -9.20 Units on a scale | Standard Error 1.35 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Overall Impact Subscale | -2.94 Units on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Function Subscale | -11.45 Units on a scale | Standard Error 1.79 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Overall Impact Subscale | -2.95 Units on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Symptom Subscale | -10.05 Units on a scale | Standard Error 1.51 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Overall Impact Subscale | -3.80 Units on a scale | Standard Error 0.49 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Function Subscale: | -8.48 Units on a scale | Standard Error 1.47 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Overall Impact Subscale | -4.66 Units on a scale | Standard Error 0.49 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Function Subscale: | -9.97 Units on a scale | Standard Error 1.46 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Function Subscale | -12.08 Units on a scale | Standard Error 1.66 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Function Subscale | -14.04 Units on a scale | Standard Error 1.82 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Symptom Subscale | -10.54 Units on a scale | Standard Error 1.34 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Symptom Subscale | -13.78 Units on a scale | Standard Error 1.5 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 8: Symptom Subscale | -14.20 Units on a scale | Standard Error 1.68 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 2: Overall Impact Subscale | -3.94 Units on a scale | Standard Error 0.45 |
| ASP0819 15 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales | Week 4: Overall Impact Subscale | -4.29 Units on a scale | Standard Error 0.45 |
Comparison: Function Subscale: Week 2p-value: 0.23590% CI: [-4.86, 1.9]MMRM
Comparison: Function Subscale: Week 4p-value: 0.10390% CI: [-6.84, 0.89]MMRM
Comparison: Function Subscale: Week 8p-value: 0.15490% CI: [-6.78, 1.6]MMRM
Comparison: Symptoms Subscale: Week 2p-value: 0.23890% CI: [-4.45, 1.77]MMRM
Comparison: Symptoms Subscale: Week 4p-value: 0.03990% CI: [-7.22, -0.24]MMRM
Comparison: Symptoms Subscale: Week 8p-value: 0.09790% CI: [-6.93, 0.81]MMRM
Comparison: Overall Impact Subscale: Week 2p-value: 0.05790% CI: [-2.03, 0.04]MMRM
Comparison: Overall Impact Subscale: Week 4p-value: 0.01890% CI: [-2.39, -0.29]MMRM
Comparison: Overall Impact Subscale: Week 8p-value: 0.11190% CI: [-2.02, 0.3]MMRM
Secondary
Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS
The mean daily average pain score is assessed by NRS.The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine.
Time frame: Baseline and EOT (Up to week 8)
Population: FAS population with last observation carried forward (LOCF) imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS | 30.9 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS | 37.8 Percentage of participants |
p-value: 0.20290% CI: [-5.2, 19.1]Fisher Exact
Secondary
Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS
The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine.
Time frame: Baseline and EOT (Up to week 8)
Population: FAS population with LOCF Imputation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS | 12.8 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS | 18.9 Percentage of participants |
p-value: 0.17490% CI: [-6.2, 18.1]Fisher Exact
Secondary
Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS
The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine.
Time frame: Baseline and week 8
Population: FAS with population with BOCF imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | 13.8 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | 15.6 Percentage of participants |
p-value: 0.45190% CI: [-10.5, 13.8]Fisher Exact
Secondary
Percentage of Participants Achieving Greater Than or Equal to (≥)30 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS
The mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine.
Time frame: Baseline and week 8
Population: FAS population with baseline observation carried forward (BOCF) imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (≥)30 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | 29.8 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants Achieving Greater Than or Equal to (≥)30 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS | 30.0 Percentage of participants |
p-value: 0.55190% CI: [-11.9, 12.5]Fisher Exact
Secondary
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC)
The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. PGIC score ranges from 1 to 7, where 1 anchors Very Much Improved and 7 anchors Very Much Worse.
Time frame: Weeks 2, 4, and EOT (Up to week 8)
Population: FAS population with LOCF imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Much Worse | 2.1 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Minimally Worse | 13.8 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Much Improved | 9.6 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Much Worse | 3.2 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Very Much Worse | 1.1 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Very Much Worse | 0 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: No Change | 44.7 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Very much improved | 6.4 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Very much improved | 3.2 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Much Improved | 18.1 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Very much improved | 3.2 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Minimally Improved | 26.6 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Much Improved | 14.9 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: No Change | 38.3 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Minimally Worse | 7.4 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Minimally Worse | 8.5 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Minimally Improved | 31.9 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Much Worse | 2.1 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: No Change | 33.0 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Very Much Worse | 0 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Minimally Improved | 31.9 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Very Much Worse | 1.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Very much improved | 2.2 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Much Improved | 12.2 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Minimally Improved | 42.2 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: No Change | 34.4 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Minimally Worse | 3.3 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Much Worse | 4.4 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 2: Very Much Worse | 1.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Very much improved | 4.4 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Much Improved | 20.0 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Minimally Improved | 28.9 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: No Change | 37.8 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Minimally Worse | 3.3 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Much Worse | 4.4 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 4: Very Much Worse | 1.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Very much improved | 10.0 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Much Improved | 21.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Minimally Improved | 21.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: No Change | 40.0 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Minimally Worse | 3.3 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week EOT: Much Worse | 3.3 Percentage of participants |
Comparison: Week 2p-value: 0.19290% CI: [0.91, 2.24]Likelihood test
Comparison: Week 4p-value: 0.28590% CI: [0.86, 2.07]Likelihod test
Comparison: EOTp-value: 0.48690% CI: [0.78, 1.87]Likelihood test
Secondary
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC)
The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. PGIC score ranges from 1 to 7, where 1 anchors Very Much Improved and 7 anchors Very Much Worse.
Time frame: Week 8
Population: FAS population with modified last observation carried forward (mLOCF) imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Very Much Worse | 0 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Very much improved | 6.4 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Much Improved | 18.1 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Minimally Improved | 24.5 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: No Change | 40.4 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Minimally Worse | 8.5 Percentage of participants |
| Placebo | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Much Worse | 2.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Very Much Worse | 0 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: No Change | 42.2 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Very much improved | 10.0 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Much Worse | 2.2 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Much Improved | 21.1 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Minimally Worse | 3.3 Percentage of participants |
| ASP0819 15 mg | Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) | Week 8: Minimally Improved | 21.1 Percentage of participants |
Comparison: Week 8p-value: 0.30590% CI: [0.85, 2.05]Likelihood test