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

This study has been completed.
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Endo Pharmaceuticals Identifier:
First received: January 25, 2009
Last updated: August 20, 2012
Last verified: August 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

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 ]

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 ]

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
Other: 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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00830154

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

Additional Information:
Responsible Party: Endo Pharmaceuticals Identifier: NCT00830154     History of Changes
Other Study ID Numbers: IP456-041
Study First Received: January 25, 2009
Last Updated: August 20, 2012

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

Additional relevant MeSH terms:
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on August 16, 2017