Trial Outcomes & Findings for PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT03618030)

NCT ID: NCT03618030

Last Updated: 2021-07-26

Results Overview

PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 288 participants
• Primary outcome timeframe: Full-day ALC - 13 hours
• Results posted on: 2021-07-26

Participant Flow

Of the 288 subjects who were screened, 239 subjects were randomized to the double-blind period and were assessed during the full-day adult laboratory classroom (ALC) visit.

All subjects started on PRC-063 25 mg and were titrated up to his/her optimal dose (25, 35, 45, 55, 70, 85, or 100 mg/day) during the dose optimization period. The primary efficacy endpoint compared all doses of PRC-063 combined versus Placebo.

Participant milestones

Measure	PRC-063 25 mg PRC-063 oral capsules: Daily dose	PRC-063 35 mg PRC-063 oral capsules: Daily dose	PRC-063 45 mg PRC-063 oral capsules: Daily dose	PRC-063 55 mg PRC-063 oral capsules: Daily dose	PRC-063 70 mg PRC-063 oral capsules: Daily dose	PRC-063 85 mg PRC-063 oral capsules: Daily dose	PRC-063 100 mg PRC-063 oral capsules: Daily dose	Placebo Treatment Matched placebo Placebo oral capsules: Daily dose
Overall Study STARTED	15	14	21	39	36	27	18	118
Overall Study COMPLETED	3	3	13	30	29	21	14	108
Overall Study NOT COMPLETED	12	11	8	9	7	6	4	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	Active Treatment n=121 Participants PRC-063 (all doses combined) PRC-063 oral capsules: Daily dose	Placebo Treatment n=118 Participants Matched placebo Placebo oral capsules: Daily dose	Total n=239 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 10.76 • n=93 Participants	32.8 years STANDARD_DEVIATION 10.95 • n=4 Participants	33.6 years STANDARD_DEVIATION 10.88 • n=27 Participants
Sex: Female, Male Female	66 Participants n=93 Participants	64 Participants n=4 Participants	130 Participants n=27 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	54 Participants n=4 Participants	109 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	2 Participants n=4 Participants	5 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	24 Participants n=93 Participants	21 Participants n=4 Participants	45 Participants n=27 Participants
Race (NIH/OMB) White	90 Participants n=93 Participants	90 Participants n=4 Participants	180 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: Full-day ALC - 13 hours

Population: The full analysis (FA) population was the group of subjects who were randomized and received at least one dose of double-blind study drug, attended the full-day ALC visit evaluation, and had at least one post-dose PERMP-T evaluation during the full-day ALC visit. The primary efficacy endpoint compared all doses of PRC-063 versus Placebo.

PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome.

Outcome measures

Measure	Double-Blind Active Treatment n=116 Participants PRC-063 (all doses combined) PRC-063 oral capsules: Daily dose	Double-Blind Placebo Treatment n=113 Participants Matched placebo Placebo oral capsules: Daily dose
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit	302.9 score on a scale Standard Error 3.50	286.6 score on a scale Standard Error 3.52

Adverse Events

Dose-Optimization

Serious events: 1 serious events

Other events: 167 other events

Deaths: 0 deaths

Double-Blind PRC-063 25 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double-Blind PRC-063 35 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Double-Blind PRC-063 45 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Double-Blind PRC-063 55 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Double-Blind PRC-063 70 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Double-Blind PRC-063 85 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Double-Blind PRC-063 100 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Double-Blind Placebo Treatment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose-Optimization n=285 participants at risk PRC-063 25, 35, 45, 55, 70, 85, or 100 mg oral capsules: Daily dose	Double-Blind PRC-063 25 mg n=3 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 35 mg n=4 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 45 mg n=15 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 55 mg n=31 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 70 mg n=30 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 85 mg n=22 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 100 mg n=16 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind Placebo Treatment n=118 participants at risk Matched placebo Placebo oral capsules: Daily dose
Psychiatric disorders Paranoia	0.35% 1/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.

Other adverse events

Measure	Dose-Optimization n=285 participants at risk PRC-063 25, 35, 45, 55, 70, 85, or 100 mg oral capsules: Daily dose	Double-Blind PRC-063 25 mg n=3 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 35 mg n=4 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 45 mg n=15 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 55 mg n=31 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 70 mg n=30 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 85 mg n=22 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind PRC-063 100 mg n=16 participants at risk PRC-063 oral capsules: Daily dose	Double-Blind Placebo Treatment n=118 participants at risk Matched placebo Placebo oral capsules: Daily dose
Nervous system disorders Headache	21.4% 61/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	6.7% 1/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	3.3% 1/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	4.5% 1/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	12.5% 2/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	2.5% 3/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Metabolism and nutrition disorders Decreased Appetite	21.4% 61/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	4.5% 1/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Psychiatric disorders Insomnia	16.1% 46/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	6.7% 2/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	4.5% 1/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	1.7% 2/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Psychiatric disorders Irritability	9.5% 27/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	9.1% 2/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Infections and infestations Upper Respiratory Tract Infection	9.1% 26/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	3.2% 1/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	6.2% 1/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	2.5% 3/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Gastrointestinal disorders Dry Mouth	8.8% 25/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Gastrointestinal disorders Nausea	7.0% 20/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	6.7% 1/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	3.2% 1/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Psychiatric disorders Anxiety	6.0% 17/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	4.5% 1/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
General disorders Fatigue	5.3% 15/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	3.2% 1/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	3.3% 1/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	9.1% 2/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.85% 1/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/285 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/3 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	25.0% 1/4 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/15 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/31 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/30 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	4.5% 1/22 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/16 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.	0.00% 0/118 • 12 weeks Safety population: subjects who received at least 1 dose of drug/had at least 1 post-dose safety assessment (N=285 in dose-optimization period; N=239 in double-blind). Since most subjects received multiple dose levels during the dose-optimization period and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s) during the dose-optimization period, the adverse events for this period are presented for all dose levels combined.

Additional Information

Clinical Leader

Purdue Pharma L.P.

Phone: 1-800-733-1333

Email: Sailaja.Bhaskar@ImbriumThera.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER