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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00830154
First received: January 25, 2009
Last updated: August 20, 2012
Last verified: August 2012

January 25, 2009
August 20, 2012
February 2009
January 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: Weeks 8, 16 and 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830154 on ClinicalTrials.gov Archive Site
Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stuttering
  • Drug: pagoclone
    0.30 mg BID, 0.60 mg BID
  • Other: placebo
    placebo
  • Experimental: 1
    0.30 mg pagoclone BID
    Intervention: Drug: pagoclone
  • Experimental: 2
    0.60 mg pagoclone BID
    Intervention: Drug: pagoclone
  • Placebo Comparator: 3
    placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
January 2011
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830154
IP456-041
No
Endo Pharmaceuticals
Endo Pharmaceuticals
Teva Pharmaceuticals USA
Not Provided
Endo Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP