ADHD
Conditions
Brief summary
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults
Interventions
Daily dose
Daily dose
Sponsors
Purdue Pharma, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females 18 to 60 years of age 2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional 3. Subject is willing and able to comply with all the protocol requirements.
Exclusion criteria
1. Primary and/or comorbid psychiatric diagnosis other than ADHD 2. Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug; 3. Has used any investigational drug within 30 days of the screening visit;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | Full-day ALC - 13 hours | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment PRC-063 (all doses combined)
PRC-063 oral capsules: Daily dose | 121 |
| Placebo Treatment Matched placebo
Placebo oral capsules: Daily dose | 118 |
| Total | 239 |
Baseline characteristics
| Characteristic | Total | Active Treatment | Placebo Treatment |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 10.88 | 34.1 years STANDARD_DEVIATION 10.76 | 32.8 years STANDARD_DEVIATION 10.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 24 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 180 Participants | 90 Participants | 90 Participants |
| Sex: Female, Male Female | 130 Participants | 66 Participants | 64 Participants |
| Sex: Female, Male Male | 109 Participants | 55 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 285 | 0 / 3 | 0 / 4 | 0 / 15 | 0 / 31 | 0 / 30 | 0 / 22 | 0 / 16 | 0 / 118 |
| other Total, other adverse events | 167 / 285 | 0 / 3 | 1 / 4 | 2 / 15 | 3 / 31 | 4 / 30 | 7 / 22 | 3 / 16 | 9 / 118 |
| serious Total, serious adverse events | 1 / 285 | 0 / 3 | 0 / 4 | 0 / 15 | 0 / 31 | 0 / 30 | 0 / 22 | 0 / 16 | 0 / 118 |
Outcome results
Primary
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-Blind Active Treatment | 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 3.5 |
| Double-Blind Placebo Treatment | Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | 286.6 score on a scale | Standard Error 3.52 |
Comparison: The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.p-value: 0.0003ANOVA