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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830154
First Posted: January 27, 2009
Last Update Posted: August 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Endo Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830154


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

Additional Information:
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00830154     History of Changes
Other Study ID Numbers: IP456-041
First Submitted: January 25, 2009
First Posted: January 27, 2009
Last Update Posted: August 28, 2012
Last Verified: August 2012

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