Trial Outcomes & Findings for PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD (NCT NCT03172481)

Last Updated: 2019-11-05

Results Overview

The SKAMP rating scale is a validated tool that assesses behavioral symptoms of ADHD in a classroom setting. The SKAMP-C comprises 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13), and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0 = none, 6 = maximal impairment), for a total possible combined score of 0 to 78 (lower score indicated fewer ADHD symptoms). During the Full-day Classroom visit, SKAMP-C was assessed at pre-dose and approximately 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose. Average post-dose score and change from pre-dose score were analyzed on the individual SKAMP-C scores.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

156 participants

Primary outcome timeframe

Full-day Classroom - 13 hrs

Results posted on

2019-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	PRC-063 PRC-063 25, 35, 45, 55, 70 or 85 mg PRC-063 oral capsules: Daily dose	Placebo Placebo oral capsules: Daily dose
Open-label STARTED	156	0
Open-label COMPLETED	148	0
Open-label NOT COMPLETED	8	0
Double-blind STARTED	75	73
Double-blind COMPLETED	74	73
Double-blind NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PRC-063 PRC-063 25, 35, 45, 55, 70 or 85 mg PRC-063 oral capsules: Daily dose	Placebo Placebo oral capsules: Daily dose
Double-blind Withdrawal by Subject	1	0

Baseline Characteristics

PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRC-063 n=74 Participants PRC-063 25, 35, 45, 55, 70 or 85 mg PRC-063 oral capsules: Daily dose	Placebo n=73 Participants Placebo oral capsules: Daily dose	Total n=147 Participants Total of all reporting groups
Age, Customized Age	9.4 years STANDARD_DEVIATION 1.89 • n=5 Participants	9.4 years STANDARD_DEVIATION 1.83 • n=7 Participants	9.4 years STANDARD_DEVIATION 1.85 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	34 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	73 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: Full-day Classroom - 13 hrs

Outcome measures

Outcome measures
Measure	PRC-063 n=74 Participants PRC-063 25, 35, 45, 55, 70 or 85 mg PRC-063 oral capsules: Daily dose	Placebo n=73 Participants Placebo oral capsules: Daily dose
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom	11.4 score on SKAMP-C Standard Deviation 6.9	18.2 score on SKAMP-C Standard Deviation 9.0

Adverse Events

PRC-063

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PRC-063 n=74 participants at risk PRC-063 25, 35, 45, 55, 70 or 85 mg PRC-063 oral capsules: Daily dose	Placebo n=73 participants at risk Placebo oral capsules: Daily dose
Investigations Heart Rate Increased	4.1% 3/74 • Number of events 3 • 12 weeks	1.4% 1/73 • Number of events 1 • 12 weeks
Cardiac disorders Sinus Tachycardia	1.4% 1/74 • Number of events 1 • 12 weeks	2.7% 2/73 • Number of events 2 • 12 weeks
Gastrointestinal disorders Vomiting	2.7% 2/74 • Number of events 2 • 12 weeks	0.00% 0/73 • 12 weeks
Nervous system disorders Headache	2.7% 2/74 • Number of events 2 • 12 weeks	0.00% 0/73 • 12 weeks
Infections and infestations Upper Respiratory Tract Infection	2.7% 2/74 • Number of events 2 • 12 weeks	0.00% 0/73 • 12 weeks

Additional Information

Clinical Leader

Purdue Pharma L.P.

Phone: 1-800-733-1333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place