EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

NCT ID: NCT00216255

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Developmental Stuttering

Keywords

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Persistent Developmental Stuttering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pagoclone

.15mg, .30mg, .60mg

Group Type EXPERIMENTAL

Pagoclone

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pagoclone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pivotal Research Centers

Peoria, Arizona, United States

Site Status

University of California, Irvine Medical School

Orange, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

Site Status

University of South Florida College of Medicine

Tampa, Florida, United States

Site Status

Atlanta Institute of Medicine & Research-Atlanta Clinic

Atlanta, Georgia, United States

Site Status

Davis Clinic PC

Indianapolis, Indiana, United States

Site Status

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Pivotal Research Centers

Royal Oak, Michigan, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

Social Psychiatry Research Institute

New York, New York, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

University of Texas, Health Science Center

San Antonio, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IP456-039

Identifier Type: -

Identifier Source: org_study_id