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EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00216255
First Posted: September 22, 2005
Last Update Posted: September 3, 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.
Information provided by (Responsible Party):
Endo Pharmaceuticals
  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 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Effects of Pagaclone [ Time Frame: 8 weeks double blind followed by a 52 weeks open label ]
    Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore, the Subjective Screening of Stuttering (SSS) Severity Subscore, and the treatment and week 8 visits. All efficacy assessments will evaluate change from pre-treatment to each on-treatment week.


Secondary Outcome Measures:
  • Secondary Objectives [ Time Frame: Pre-treatment through week 8 ]
    SSI-3 Total overall Score and individual subscores (including frequency, duration, and physical concomitant subscores) Subjective Screening of Stuttering (SSS) test Speech Naturalness Scales (SNS) Liebowitz Social Anxiety Scale (LSAS) Stuttering Clinician's Global Impression-Improvement (CGI) Optional Neuropsychological Test Optional Functional Brain Imaging


Enrollment: 120
Study Start Date: April 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pagoclone
.15mg, .30mg, .60mg
Drug: Pagoclone
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00216255


Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, California
University of California, Irvine Medical School
Orange, California, United States, 92868
Pharmacology Research Institute
Riverside, California, United States, 92506
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
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
Endo Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00216255     History of Changes
Other Study ID Numbers: IP456-039
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Endo Pharmaceuticals:
Persistent Developmental Stuttering

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms