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Trial record 1 of 1 for:    IP456-041
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A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

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. Identifier: NCT00830154
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : August 28, 2012
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Stuttering Drug: pagoclone Other: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00830154

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United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Teva Pharmaceuticals USA
Additional Information:
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Responsible Party: Endo Pharmaceuticals Identifier: NCT00830154    
Other Study ID Numbers: IP456-041
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012
Keywords provided by Endo Pharmaceuticals:
Adults with a history of stuttering
Additional relevant MeSH terms:
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Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases