NCT03375021

CX717 in the Treatment of Adult ADHD

A Randomized, Double-Blind, Tw0-Period Crossover Study to Assess the Efficacy and Safety of the Ampakine® Compound, CX717, Versus Placebo in Adults With Attention-Deficit Hyperactive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: RespireRx · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Two-Period Crossover Study to Assess the Efficacy And Safety of the Ampakine® Compound, CX717, versus Placebo in Adults with Attention-Deficit Hyperactivity Disorder

Detailed description

This study examined the clinical efficacy, tolerability and safety of CX717 in the treatment of adults with ADHD. The study was a double-blind, 2-period crossover study that compared 2 different doses of CX717 with placebo. Subjects were randomized to 1 of 4 different treatment sequences: placebo - low dose; low dose - placebo; placebo - high dose; or high dose - placebo. Each treatment period was 3 weeks with a 2-week washout between treatment periods. The doses chosen were 200 mg b.i.d. and 800 mg b.i.d.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	CX717 200 mg	CX717 200 mg capsules BID
DRUG	CX717 800 mg	CX717 4 X 200 mg capsules BID
DRUG	Placebo	Placebo 200 mg or 800 mg capsules BID

Timeline

• Start date: 2005-07-19
• Primary completion: 2006-01-10
• Completion: 2006-01-10
• First posted: 2017-12-15
• Last updated: 2017-12-15

Regulatory

• FDA-regulated drug study