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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | PRC-063 25, 35, 45, 55, 70, 85, or 100 mg |
|
| Placebo Treatment | Placebo Comparator | Matched placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRC-063 oral capsules | Drug | Daily dose |
| |
| Placebo oral capsules |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Full-day ALC - 13 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sailaja Bhaskar, PhD | Purdue Pharma, Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridien Research Inc. | Bradenton | Florida | 34201 | United States | ||
| Meridien Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34189995 | Derived | Childress A, Cutler AJ, Marraffino AH, Bhaskar S, Donnelly G. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD. J Atten Disord. 2022 Apr;26(6):857-869. doi: 10.1177/10870547211025610. Epub 2021 Jun 30. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRC-063 25 mg | PRC-063 oral capsules: Daily dose |
| FG001 | PRC-063 35 mg | PRC-063 oral capsules: Daily dose |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 |
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| Drug |
Daily dose |
|
| Lakeland |
| Florida |
| 33805 |
| United States |
| Meridien Research Inc. | Maitland | Florida | 32751 | United States |
| South Shore Psychiatric Services | Hingham | Massachusetts | 02043 | United States |
| Center for Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Center for Psychiatry and Behavioral Medicine | Durham | North Carolina | 27705 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17004 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| FG002 |
| PRC-063 45 mg |
PRC-063 oral capsules: Daily dose |
| FG003 | PRC-063 55 mg | PRC-063 oral capsules: Daily dose |
| FG004 | PRC-063 70 mg | PRC-063 oral capsules: Daily dose |
| FG005 | PRC-063 85 mg | PRC-063 oral capsules: Daily dose |
| FG006 | PRC-063 100 mg | PRC-063 oral capsules: Daily dose |
| FG007 | Placebo Treatment | Matched placebo Placebo oral capsules: Daily dose |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | PRC-063 (all doses combined) PRC-063 oral capsules: Daily dose |
| BG001 | Placebo Treatment | Matched placebo Placebo oral capsules: Daily dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Full-day ALC - 13 hours |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-Optimization | PRC-063 25, 35, 45, 55, 70, 85, or 100 mg oral capsules: Daily dose | 0 | 285 | 1 | 285 | 167 | 285 |
| EG001 | Double-Blind PRC-063 25 mg | PRC-063 oral capsules: Daily dose | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Double-Blind PRC-063 35 mg | PRC-063 oral capsules: Daily dose | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Double-Blind PRC-063 45 mg | PRC-063 oral capsules: Daily dose | 0 | 15 | 0 | 15 | 2 | 15 |
| EG004 | Double-Blind PRC-063 55 mg | PRC-063 oral capsules: Daily dose | 0 | 31 | 0 | 31 | 3 | 31 |
| EG005 | Double-Blind PRC-063 70 mg | PRC-063 oral capsules: Daily dose | 0 | 30 | 0 | 30 | 4 | 30 |
| EG006 | Double-Blind PRC-063 85 mg | PRC-063 oral capsules: Daily dose | 0 | 22 | 0 | 22 | 7 | 22 |
| EG007 | Double-Blind PRC-063 100 mg | PRC-063 oral capsules: Daily dose | 0 | 16 | 0 | 16 | 3 | 16 |
| EG008 | Double-Blind Placebo Treatment | Matched placebo Placebo oral capsules: Daily dose | 0 | 118 | 0 | 118 | 9 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paranoia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma L.P. | 1-800-733-1333 | Sailaja.Bhaskar@ImbriumThera.com |
| Jan 21, 2021 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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