Trial Outcomes & Findings for A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression (NCT NCT03044249)

Last Updated: 2021-04-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Week 10

Results posted on

2021-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.	MP-101 Week 0: Participants received 20 milligrams (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 ).
Overall Study STARTED	42	39
Overall Study Received at Least One Dose of Study Drug	42	39
Overall Study COMPLETED	32	25
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.	MP-101 Week 0: Participants received 20 milligrams (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 ).
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

A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=42 Participants Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.	MP-101 n=39 Participants 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 ).	Total n=81 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	75.3 years STANDARD_DEVIATION 9.44 • n=93 Participants	74.0 years STANDARD_DEVIATION 7.66 • n=4 Participants	74.7 years STANDARD_DEVIATION 8.60 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	27 Participants n=4 Participants	55 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants	33 Participants n=4 Participants	63 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	37 Participants n=93 Participants	34 Participants n=4 Participants	71 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment Canada	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	40 Participants n=93 Participants	36 Participants n=4 Participants	76 Participants n=27 Participants
Neuropsychiatric Inventory (NPI) Psychosis Score	8.4 units on a scale STANDARD_DEVIATION 6.36 • n=93 Participants	7.7 units on a scale STANDARD_DEVIATION 5.70 • n=4 Participants	8.0 units on a scale STANDARD_DEVIATION 6.02 • n=27 Participants
NPI Agitation/Aggression Score	5.8 units on a scale STANDARD_DEVIATION 3.34 • n=93 Participants	5.3 units on a scale STANDARD_DEVIATION 3.15 • n=4 Participants	5.5 units on a scale STANDARD_DEVIATION 3.24 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=26 Participants 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 ).
Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score	58 percentage of participants	62 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=25 Participants 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 ).
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	8.0 percentage of participants
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	28.0 percentage of participants
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	28.0 percentage of participants
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	16.0 percentage of participants
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	12.0 percentage of participants
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	8.0 percentage of participants
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	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=26 Participants 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 ).
Change From Baseline in NPI Total Score	-3.43 score on a scale Standard Error 2.34	-8.70 score on a scale Standard Error 2.66

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=26 Participants 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 ).
Change From Baseline in NPI Core Total Score	-3.46 score on a scale Standard Error 1.15	-5.05 score on a scale Standard Error 1.31

SECONDARY outcome

Timeframe: Week 10

Population: All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores.

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.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=26 Participants 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 ).
Number of Participants With NPI Caregiver Distress Week 10 Delusions ( Not at all)	0 Participants	0 Participants
Number of Participants With NPI Caregiver Distress Week 10 Delusions ( Minimally)	1 Participants	1 Participants
Number of Participants With NPI Caregiver Distress Week 10 Delusions (Mildly)	9 Participants	5 Participants
Number of Participants With NPI Caregiver Distress Week 10 Delusions (Moderately)	7 Participants	3 Participants
Number of Participants With NPI Caregiver Distress Week 10 Delusions (severely)	1 Participants	2 Participants
Number of Participants With NPI Caregiver Distress Week 10 Delusions (Very Severely or extremely)	1 Participants	0 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations ( Not at all)	3 Participants	1 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations ( Minimally)	3 Participants	3 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations (Mildly)	3 Participants	4 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations (Moderately)	6 Participants	2 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations (severely)	1 Participants	1 Participants
Number of Participants With NPI Caregiver Distress Week 10 Hallucinations (Very Severely or extremely)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=25 Participants 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 ).
Change From Baseline in NPI Domains - Anxiety	-0.1 units on a scale Standard Deviation 3.53	-0.6 units on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: Baseline Up to 10 Weeks

Population: All randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=39 Participants 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 ).
Number of Participants With Any Treatment Emergent Adverse Event	24 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=26 Participants 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 ).
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III	-0.29 units on a scale Standard Error 0.76	-0.37 units on a scale Standard Error 0.87

SECONDARY outcome

Timeframe: 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.

Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.	MP-101 n=34 Participants 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 ).
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	429.8 Nanomoles per liter (nmol/L) Geometric Coefficient of Variation 1.00
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
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	249 Nanomoles per liter (nmol/L) Geometric Coefficient of Variation 1.01
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	808.4 Nanomoles per liter (nmol/L) Geometric Coefficient of Variation 1.00
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	929 Nanomoles per liter (nmol/L) Geometric Coefficient of Variation 1.00
Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite Early Termination	NA Nanomoles per liter (nmol/L) Geometric Coefficient of Variation NA For N=1, individual value 1 was reported.	13.0 Nanomoles per liter (nmol/L) Geometric Coefficient of Variation 1.24

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

MP-101

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=42 participants at risk Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.	MP-101 n=39 participants at risk Week 0: Participants received 20 milligrams (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 ).
Infections and infestations Pneumonia	4.8% 2/42 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	0.00% 0/39 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Infections and infestations Sepsis	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	0.00% 0/39 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Nervous system disorders Dementia	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Nervous system disorders Unresponsive to stimuli	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Psychiatric disorders Abnormal behaviour	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.6% 1/39 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Psychiatric disorders Psychotic disorder	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	0.00% 0/39 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Psychiatric disorders Suicidal ideation	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	0.00% 0/39 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	0.00% 0/39 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo n=42 participants at risk Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.	MP-101 n=39 participants at risk Week 0: Participants received 20 milligrams (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 ).
Gastrointestinal disorders Nausea	4.8% 2/42 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	10.3% 4/39 • Number of events 4 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	10.3% 4/39 • Number of events 4 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
General disorders Fatigue	4.8% 2/42 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	7.7% 3/39 • Number of events 3 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	5.1% 2/39 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	7.1% 3/42 • Number of events 3 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	7.7% 3/39 • Number of events 4 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	2.4% 1/42 • Number of events 1 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	10.3% 4/39 • Number of events 4 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/42 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	5.1% 2/39 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	4.8% 2/42 • Number of events 2 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.	12.8% 5/39 • Number of events 5 • Baseline Up To 10 Weeks All randomized participants who received at least one dose of study drug.

Additional Information

Chief Executive Officer

Mediti Pharma Inc.

Phone: 1-514-993-7207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60