A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
- Registration Number
- NCT00830154
- Lead Sponsor
- Endo Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 placebo placebo 1 pagoclone 0.30 mg pagoclone BID 2 pagoclone 0.60 mg pagoclone BID
- Primary Outcome Measures
Name Time Method To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo. Weeks 8, 16 and 24
- Secondary Outcome Measures
Name Time Method Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores. 24 weeks