Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: centanafadine sustained-release Attention-Deficit Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 85
Healthy volunteers: no

Brief summary:
This was a Phase 2b, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover study to evaluate safety and efficacy of CTN SR compared with placebo in adults with ADHD. Efficacy was also evaluated in the subgroup of adults with ADHD treated with a target CTN SR dose of 400 mg/day.

Detailed description:

Arms:
arm 1: Participants received CTN SR tablets starting at a dose of 100 or 200 milligrams (mg) on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common total daily dose (TDD) was 400 mg/day. arm 2: Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.

Interventions: intervention 1: CTN SR intervention 2: Matching placebo
Intervention descriptions: intervention 1: CTN SR tablets, daily, Orally. intervention 2: Matching-placebo tablets daily, orally.

Protocol document: