A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering - Full Text View

Sponsor:	Endo Pharmaceuticals
Collaborator:	Teva Pharmaceuticals USA
Information provided by (Responsible Party):	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00830154

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 II Phase III

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

Drug Information available for: Pagoclone

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:	January 12, 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 February 09, 2012