Conditions: ADHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 375
Healthy volunteers: no

Brief summary:
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD

Detailed description:
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.

Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.

Arms:
arm 1: Placebo Arm arm 2: PRC-063 25 mg arm 3: PRC-063 45 mg arm 4: PRC-063 70 mg arm 5: PRC-063 100 mg

Interventions: intervention 1: Placebo intervention 2: PRC-063 25 mg intervention 3: PRC-063 45 mg intervention 4: PRC-063 70 mg intervention 5: PRC-063 100 mg
Intervention descriptions: intervention 1: Oral placebo capsule intervention 2: Oral 25 mg capsule - active intervention 3: Oral 45 mg capsule - active intervention 4: Oral 70 mg capsule - active intervention 5: Oral 100 mg capsule - active

Protocol document: