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

Stuttering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830154
• Other study ID #: IP456-041
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 25, 2009
• Last updated: August 20, 2012
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stuttering

Intervention

Drug:
• pagoclone
0.30 mg BID, 0.60 mg BID

Other:
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

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