NCT00830154

A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.

Detailed description

A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.

Conditions

• Stuttering

Interventions

Type	Name	Description
DRUG	pagoclone	0.30 mg BID, 0.60 mg BID
OTHER	placebo	placebo

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2009-01-27
• Last updated: 2012-08-28

Locations

1 site across 1 country: United States