Aggression, Agitation, Alzheimer Dementia, Dementia, Psychosis
Conditions
Keywords
Psychotic Disorders
Brief summary
A ten-week study to assess MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression
Interventions
DRUGMP-101
Capsules
DRUGPlacebo
Capsules
Sponsors
Mediti Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females must be of non-childbearing potential, defined as women greater than or equal to (≥) 60 years of age, postmenopausal women ≥50 and less than (\<) 60 years of age who have had a cessation of menses for at least 12 months, or women who are congenitally or surgically sterile * Males must agree to use 2 forms of highly effective birth control with female partners of childbearing potential while enrolled in the study, and for at least 28 days following the last dose * Ambulatory (with or without walking device) with a stable gait * Have a Mini-Mental State Examination (MMSE) score of 10 to 24 * Meet clinical criteria for one of the following disorders: dementia associated with Parkinson's disease, dementia with Lewy bodies, possible or probable Alzheimer's disease, frontotemporal degeneration spectrum disorders, vascular dementia * Able to communicate verbally * Have an NPI score of ≥4 on either individual item (delusions or hallucinations) or ≥6 on the Psychosis Subscale (combined delusions and hallucinations), or an NPI score of ≥4 on agitation/aggression domain * Have a reliable caregiver who provides written informed consent to participate and who is in frequent contact with the patient (defined as spending at least 4 hours/day at least 4 days/week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors). The caregiver must be able to communicate with site personnel, and opinion of the investigator, must understand the written protocol-specified questionnaires. If a caregiver cannot continue, one replacement caregiver will be allowed if the above criterion is met * Must be on a stable dose of cholinesterase inhibitor and/or memantine, if applicable * If taking antipsychotic drugs or any drug intended to treat psychosis, must be on a stable treatment regimen for ≥1 month prior to the study * Have venous access sufficient to allow for blood sampling per the protocol * Have clinical laboratory test results within normal reference range for the population or investigative site * Are capable of participating in all study assessments * Are able and willing to provide consent (patients and caregivers)
Exclusion criteria
* Have a history of significant psychotic disorders (including, schizophrenia, delusional disorder, substance abuse psychosis that lasted over 6 months, major depressive disorder or bipolar disorder with psychotic episodes) * Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke * Have renal impairment as defined by Estimated Glomerular Filtration Rate (eGFR) \<45 milliliters per minute per 1.73 square meters (ml/min/1.73m2) * Have significant cardiovascular, respiratory, gastrointestinal, renal, hematologic, or oncologic comorbidities that could impact patient safety and study participation over 10 weeks * Have a history of seizures or other condition that would place the patient at increased risk of seizures. * Are, in the investigator's judgment, at risk for suicide, or as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) * Have a Fridericia's corrected QT interval (QTcF) greater than (\>) 450 milliseconds (ms) for males or 470 ms for females * Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, at least 3 months (or more) must have passed * In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score | Week 10 | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). An NPI response was defined as at least a 30% improvement from baseline on the NPI Psychosis sub-score (for participants with a psychosis diagnosis (Delusions and Hallucinations)) or the NPI Aggression/Agitation sub-score (for participants with an agitation/aggression diagnosis). The delusions, hallucinations, and aggression/agitation domain scores were added together to form a core total score with score range of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in NPI Total Score | Baseline, Week 10 | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. |
| Change From Baseline in NPI Core Total Score | Baseline, Week 10 | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI CoreTotal Score is calculated by adding the Individual Item Scores for all 3 domains (hallucinations, delusions, and agitation/aggression) to yield a possible NPI Core Total Score of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. |
| Number of Participants With NPI Caregiver Distress | Week 10 | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement. |
| Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Week 10 | The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Number of Participants With Any Treatment Emergent Adverse Event | Baseline Up to 10 Weeks | Number of participants with untoward medical occurrences that emerge during the treatment period, having been absent pretreatment, or worsen relative to the pretreatment state, which do not necessarily have a causal relationship with this treatment. A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs) is located in the reported adverse events module. |
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Baseline, Week 10 | Part III of the UPDRS is an investigator-scored scale used to assess the motor symptoms of patients with Parkinson's disease. The investigator rates the patient on 14 items based on observation or the performance of a task the patient performs (even in the context of any comorbidities) on a 5-point scale. The scores range from 0 to 4, with higher scores indicating greater impairment. The total UPDRS score was calculated as the sum of all items, ranging from 0 to 56 with higher scores indicating greater impairment. If any individual item was missing, the UPDRS score was be set to missing. |
| Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 2: 4-8 hours post-dose; Week 4: Predose, 0-2 hours postdose; Week 6: 8-12 hours postdose; Week 10: 2- 4 hours;Early Termination | Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach. |
| Change From Baseline in NPI Domains - Anxiety | Baseline, 10 Weeks | The 12 individual items in NPI that quantify changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Anxiety consists of anxiety item to yield a possible NPI Score of 0 to 12. Lower score=less severity. A negative change score from baseline indicates improvement. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9. | 42 |
| MP-101 Week 0:
Participants received 20 mg MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.
Week 1:
Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.
Week 2 through Week 9:
Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ). | 39 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 9 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance with Study Drug | 1 | 0 |
| Overall Study | Study Terminated by Sponsor | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Total | Placebo | MP-101 |
|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 8.6 | 75.3 years STANDARD_DEVIATION 9.44 | 74.0 years STANDARD_DEVIATION 7.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 30 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Neuropsychiatric Inventory (NPI) Psychosis Score | 8.0 units on a scale STANDARD_DEVIATION 6.02 | 8.4 units on a scale STANDARD_DEVIATION 6.36 | 7.7 units on a scale STANDARD_DEVIATION 5.7 |
| NPI Agitation/Aggression Score | 5.5 units on a scale STANDARD_DEVIATION 3.24 | 5.8 units on a scale STANDARD_DEVIATION 3.34 | 5.3 units on a scale STANDARD_DEVIATION 3.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 71 Participants | 37 Participants | 34 Participants |
| Region of Enrollment Canada | 5 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 76 Participants | 40 Participants | 36 Participants |
| Sex: Female, Male Female | 55 Participants | 28 Participants | 27 Participants |
| Sex: Female, Male Male | 26 Participants | 14 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 1 / 39 |
| other Total, other adverse events | 12 / 42 | 22 / 39 |
| serious Total, serious adverse events | 4 / 42 | 4 / 39 |
Outcome results
Primary
Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score
The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). An NPI response was defined as at least a 30% improvement from baseline on the NPI Psychosis sub-score (for participants with a psychosis diagnosis (Delusions and Hallucinations)) or the NPI Aggression/Agitation sub-score (for participants with an agitation/aggression diagnosis). The delusions, hallucinations, and aggression/agitation domain scores were added together to form a core total score with score range of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement.
Time frame: Week 10
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores but were not withdrawn due to early termination of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score | 58 percentage of participants |
| MP-101 | Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score | 62 percentage of participants |
p-value: 0.4890% CI: [-18, 25]Fisher Exact
Secondary
Change From Baseline in NPI Core Total Score
The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI CoreTotal Score is calculated by adding the Individual Item Scores for all 3 domains (hallucinations, delusions, and agitation/aggression) to yield a possible NPI Core Total Score of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement.
Time frame: Baseline, Week 10
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in NPI Core Total Score | -3.46 score on a scale | Standard Error 1.15 |
| MP-101 | Change From Baseline in NPI Core Total Score | -5.05 score on a scale | Standard Error 1.31 |
p-value: 0.3790% CI: [-4.47, 1.31]Mixed Models Analysis
Secondary
Change From Baseline in NPI Domains - Anxiety
The 12 individual items in NPI that quantify changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Anxiety consists of anxiety item to yield a possible NPI Score of 0 to 12. Lower score=less severity. A negative change score from baseline indicates improvement.
Time frame: Baseline, 10 Weeks
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in NPI Domains - Anxiety | -0.1 units on a scale | Standard Deviation 3.53 |
| MP-101 | Change From Baseline in NPI Domains - Anxiety | -0.6 units on a scale | Standard Deviation 2.69 |
Secondary
Change From Baseline in NPI Total Score
The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.
Time frame: Baseline, Week 10
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in NPI Total Score | -3.43 score on a scale | Standard Error 2.34 |
| MP-101 | Change From Baseline in NPI Total Score | -8.70 score on a scale | Standard Error 2.66 |
p-value: 0.1490% CI: [-11.16, 0.61]Mixed Models Analysis
Secondary
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Part III of the UPDRS is an investigator-scored scale used to assess the motor symptoms of patients with Parkinson's disease. The investigator rates the patient on 14 items based on observation or the performance of a task the patient performs (even in the context of any comorbidities) on a 5-point scale. The scores range from 0 to 4, with higher scores indicating greater impairment. The total UPDRS score was calculated as the sum of all items, ranging from 0 to 56 with higher scores indicating greater impairment. If any individual item was missing, the UPDRS score was be set to missing.
Time frame: Baseline, Week 10
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | -0.29 units on a scale | Standard Error 0.76 |
| MP-101 | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | -0.37 units on a scale | Standard Error 0.87 |
p-value: 0.9490% CI: [-2, 1.84]Mixed Models Analysis
Secondary
Number of Participants With Any Treatment Emergent Adverse Event
Number of participants with untoward medical occurrences that emerge during the treatment period, having been absent pretreatment, or worsen relative to the pretreatment state, which do not necessarily have a causal relationship with this treatment. A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs) is located in the reported adverse events module.
Time frame: Baseline Up to 10 Weeks
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Any Treatment Emergent Adverse Event | 24 Participants |
| MP-101 | Number of Participants With Any Treatment Emergent Adverse Event | 24 Participants |
Secondary
Number of Participants With NPI Caregiver Distress
The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.
Time frame: Week 10
Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions ( Not at all) | 0 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions ( Minimally) | 1 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Mildly) | 9 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Moderately) | 7 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (severely) | 1 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Very Severely or extremely) | 1 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations ( Not at all) | 3 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations ( Minimally) | 3 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Mildly) | 3 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Moderately) | 6 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (severely) | 1 Participants |
| Placebo | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Very Severely or extremely) | 0 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (severely) | 1 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions ( Not at all) | 0 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations ( Not at all) | 1 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions ( Minimally) | 1 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Moderately) | 2 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Mildly) | 5 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations ( Minimally) | 3 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Moderately) | 3 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Very Severely or extremely) | 0 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (severely) | 2 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Hallucinations (Mildly) | 4 Participants |
| MP-101 | Number of Participants With NPI Caregiver Distress | Week 10 Delusions (Very Severely or extremely) | 0 Participants |
Secondary
Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10
The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 10
Population: All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline CGI-I measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | No change | 21.9 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Very much improved | 0 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Much improved | 25.0 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Minimally improved | 34.4 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Minimally worse | 15.6 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Much worse | 3.1 percentage of participants |
| Placebo | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Very much worse | 0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Minimally improved | 28.0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Very much worse | 0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | No change | 16.0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Very much improved | 8.0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Much worse | 8.0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Much improved | 28.0 percentage of participants |
| MP-101 | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | Minimally worse | 12.0 percentage of participants |
Secondary
Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite
Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach.
Time frame: Week 2: 4-8 hours post-dose; Week 4: Predose, 0-2 hours postdose; Week 6: 8-12 hours postdose; Week 10: 2- 4 hours;Early Termination
Population: All participants who received at least one dose of MP-101 and had evaluable PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 2: 4-8 hours | 7.9 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.11 |
| Placebo | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 4: 0-2 hours | 11.4 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.09 |
| Placebo | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 6: 8-12 hours | 4.1 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.36 |
| Placebo | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 10: 2- 4 hours | 9.3 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.12 |
| Placebo | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Early Termination | NA Nanomoles per liter (nmol/L) | — |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 10: 2- 4 hours | 929 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1 |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 6: 8-12 hours | 808.4 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1 |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 2: 4-8 hours | 429.8 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1 |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 4: Predose | 85.0 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.01 |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Early Termination | 13.0 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.24 |
| MP-101 | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Week 4: 0-2 hours | 249 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 1.01 |