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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
History of Changes
  Purpose

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


Condition Intervention Phase
Stuttering
 Drug: pagoclone
Other: placebo
 Phase 2
Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Stuttering
U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 321
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.30 mg pagoclone BID
 Drug: pagoclone
0.30 mg BID, 0.60 mg BID
Experimental: 2
0.60 mg pagoclone BID
 Drug: pagoclone
0.30 mg BID, 0.60 mg BID
Placebo Comparator: 3
placebo
 Other: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830154

Locations
United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Teva Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00830154     History of Changes
Other Study ID Numbers: IP456-041
Study First Received: January 25, 2009
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
stutter
stuttering
Adults with a history of stuttering

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 18, 2012