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

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Placebo oral capsules; Drug: PRC-063 oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT03618030

063-020

Details and patient eligibility

About

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

Enrollment: 288 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

288 participants in 2 patient groups, including a placebo group

Active Treatment

Experimental group

Description:

PRC-063 25, 35, 45, 55, 70, 85, or 100 mg

Treatment:

Drug: PRC-063 oral capsules

Placebo Treatment

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: Placebo oral capsules