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Trial record 1 of 1 for:    NCT03618030
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PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT03618030
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma, Canada

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition ADHD
Interventions Drug: PRC-063 oral capsules
Drug: Placebo oral capsules
Enrollment 288
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.
Arm/Group Title PRC-063 25 mg PRC-063 35 mg PRC-063 45 mg PRC-063 55 mg PRC-063 70 mg PRC-063 85 mg PRC-063 100 mg Placebo Treatment
Hide Arm/Group Description PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose

Matched placebo

Placebo oral capsules: Daily dose
Period Title: Overall Study
Started [1] 15 14 21 39 36 27 18 118
Completed 3 3 13 30 29 21 14 108
Not Completed 12 11 8 9 7 6 4 10
[1]
Randomized Treatment (in double-blind period) or Last Dose Administered (dose-optimization period)
Arm/Group Title Active Treatment Placebo Treatment Total
Hide Arm/Group Description

PRC-063 (all doses combined)

PRC-063 oral capsules: Daily dose

Matched placebo

Placebo oral capsules: Daily dose

 Total of all reporting groups
Overall Number of Baseline Participants 121 118 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 118 participants 239 participants
34.1  (10.76) 32.8  (10.95) 33.6  (10.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 118 participants 239 participants
Female
66
  54.5%
64
  54.2%
130
  54.4%
Male
55
  45.5%
54
  45.8%
109
  45.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 118 participants 239 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   2.5%
2
   1.7%
5
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
24
  19.8%
21
  17.8%
45
  18.8%
White
90
  74.4%
90
  76.3%
180
  75.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.3%
5
   4.2%
9
   3.8%
1.Primary Outcome
Title Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Double-Blind Active Treatment Double-Blind Placebo Treatment
Hide Arm/Group Description:

PRC-063 (all doses combined)

PRC-063 oral capsules: Daily dose

Matched placebo

Placebo oral capsules: Daily dose
Overall Number of Participants Analyzed 116 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
302.9  (3.50) 286.6  (3.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Active Treatment, Double-Blind Placebo Treatment
Comments The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Dose-Optimization Double-Blind PRC-063 25 mg Double-Blind PRC-063 35 mg Double-Blind PRC-063 45 mg Double-Blind PRC-063 55 mg Double-Blind PRC-063 70 mg Double-Blind PRC-063 85 mg Double-Blind PRC-063 100 mg Double-Blind Placebo Treatment
Hide Arm/Group Description PRC-063 25, 35, 45, 55, 70, 85, or 100 mg oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose PRC-063 oral capsules: Daily dose Matched placebo Placebo oral capsules: Daily dose
All-Cause Mortality
Dose-Optimization Double-Blind PRC-063 25 mg Double-Blind PRC-063 35 mg Double-Blind PRC-063 45 mg Double-Blind PRC-063 55 mg Double-Blind PRC-063 70 mg Double-Blind PRC-063 85 mg Double-Blind PRC-063 100 mg Double-Blind Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/285 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/15 (0.00%)   0/31 (0.00%)   0/30 (0.00%)   0/22 (0.00%)   0/16 (0.00%)   0/118 (0.00%) 
Hide Serious Adverse Events
Dose-Optimization Double-Blind PRC-063 25 mg Double-Blind PRC-063 35 mg Double-Blind PRC-063 45 mg Double-Blind PRC-063 55 mg Double-Blind PRC-063 70 mg Double-Blind PRC-063 85 mg Double-Blind PRC-063 100 mg Double-Blind Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/285 (0.35%)   0/3 (0.00%)   0/4 (0.00%)   0/15 (0.00%)   0/31 (0.00%)   0/30 (0.00%)   0/22 (0.00%)   0/16 (0.00%)   0/118 (0.00%) 
Psychiatric disorders                   
Paranoia † 1  1/285 (0.35%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/22 (0.00%)  0/16 (0.00%)  0/118 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose-Optimization Double-Blind PRC-063 25 mg Double-Blind PRC-063 35 mg Double-Blind PRC-063 45 mg Double-Blind PRC-063 55 mg Double-Blind PRC-063 70 mg Double-Blind PRC-063 85 mg Double-Blind PRC-063 100 mg Double-Blind Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   167/285 (58.60%)   0/3 (0.00%)   1/4 (25.00%)   2/15 (13.33%)   3/31 (9.68%)   4/30 (13.33%)   7/22 (31.82%)   3/16 (18.75%)   9/118 (7.63%) 
Gastrointestinal disorders                   
Dry Mouth † 1  25/285 (8.77%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  0/22 (0.00%)  0/16 (0.00%)  0/118 (0.00%) 
Nausea † 1  20/285 (7.02%)  0/3 (0.00%)  0/4 (0.00%)  1/15 (6.67%)  1/31 (3.23%)  0/30 (0.00%)  0/22 (0.00%)  0/16 (0.00%)  0/118 (0.00%) 
General disorders                   
Fatigue † 1  15/285 (5.26%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  1/31 (3.23%)  1/30 (3.33%)  2/22 (9.09%)  0/16 (0.00%)  1/118 (0.85%) 
Infections and infestations                   
Upper Respiratory Tract Infection † 1  26/285 (9.12%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  1/31 (3.23%)  0/30 (0.00%)  0/22 (0.00%)  1/16 (6.25%)  3/118 (2.54%) 
Metabolism and nutrition disorders                   
Decreased Appetite † 1  61/285 (21.40%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/22 (4.55%)  0/16 (0.00%)  0/118 (0.00%) 
Nervous system disorders                   
Headache † 1  61/285 (21.40%)  0/3 (0.00%)  0/4 (0.00%)  1/15 (6.67%)  0/31 (0.00%)  1/30 (3.33%)  1/22 (4.55%)  2/16 (12.50%)  3/118 (2.54%) 
Psychiatric disorders                   
Insomnia † 1  46/285 (16.14%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  2/30 (6.67%)  1/22 (4.55%)  0/16 (0.00%)  2/118 (1.69%) 
Irritability † 1  27/285 (9.47%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  2/22 (9.09%)  0/16 (0.00%)  0/118 (0.00%) 
Anxiety † 1  17/285 (5.96%)  0/3 (0.00%)  0/4 (0.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/22 (4.55%)  0/16 (0.00%)  0/118 (0.00%) 
Reproductive system and breast disorders                   
Dysmenorrhea † 1  0/285 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/15 (0.00%)  0/31 (0.00%)  0/30 (0.00%)  1/22 (4.55%)  0/16 (0.00%)  0/118 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 1-800-733-1333
EMail: Sailaja.Bhaskar@ImbriumThera.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Purdue Pharma, Canada
ClinicalTrials.gov Identifier: NCT03618030    
Other Study ID Numbers: 063-020
First Submitted: August 1, 2018
First Posted: August 7, 2018
Results First Submitted: October 29, 2020
Results First Posted: July 26, 2021
Last Update Posted: July 26, 2021