EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study - Full Text View

Sponsored by:	Indevus Pharmaceuticals
Information provided by:	Indevus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00216255

Purpose

The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.

Condition	Intervention	Phase
Persistent Developmental Stuttering	Drug: Pagoclone	Phase II

MedlinePlus related topics: Stuttering

Drug Information available for: Pagoclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo Controlled Pilot Study of Pagoclone in Patients With PDS Followed by a 52-Week Open-Label Extension

Further study details as provided by Indevus Pharmaceuticals:

Estimated Enrollment:	120
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PDS defined as DSM-IV-TR criteria, symptoms starting before age 8, and a total overall score of 18-36 on the SSI-3
English-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance
Not pregnant or breastfeeding
Able to consent

Exclusion Criteria:

No diagnoses of other CNS/Mental health disorders in the last 6 months
No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
No use of non-medicinal stuttering treatments for 5 months prior to the study
No use of illicit drugs or opiates of any kind

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216255

Locations

United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, California
Pharmacology Research Institute
Riverside, California, United States, 92506
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
University of California, Irvine Medical School
Orange, California, United States, 92868
United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33613-4788
United States, Georgia
Atlanta Institute of Medicine & Research-Atlanta Clinic
Atlanta, Georgia, United States, 30328
United States, Indiana
Davis Clinic PC
Indianapolis, Indiana, United States, 46202
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Michigan
Pivotal Research Centers
Royal Oak, Michigan, United States, 48073
United States, New York
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
Social Psychiatry Research Institute
New York City, New York, United States, 10021
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
University of Texas, Health Science Center
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Indevus Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	IP456-039
Study First Received:	September 16, 2005
Last Updated:	August 23, 2007
ClinicalTrials.gov Identifier:	NCT00216255
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indevus Pharmaceuticals:

Persistent Developmental Stuttering

Study placed in the following topic categories:

Signs and Symptoms
Speech Disorders
Neurologic Manifestations
Language Disorders

Stuttering
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009