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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborator: Teva Pharmaceuticals USA

Criteria

Inclusion Criteria:

• Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.

• Stuttering severity must be notable for > 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.

Exclusion Criteria:

• Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.