EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

August 27, 2012 updated by: Endo Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Pagoclone
.15mg, .30mg, .60mg
Drug: Pagoclone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks double blind followed by a 52 weeks open label

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-treatment through week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP456-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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