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EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Primary Purpose

Persistent Developmental Stuttering

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pagoclone
Placebo
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Developmental Stuttering focused on measuring Persistent Developmental Stuttering

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pivotal Research Centers
  • University of California, Irvine Medical School
  • Pharmacology Research Institute
  • Pacific Clinical Research Medical Group
  • University of South Florida College of Medicine
  • Atlanta Institute of Medicine & Research-Atlanta Clinic
  • Davis Clinic PC
  • Vince and Associates Clinical Research
  • Pivotal Research Centers
  • Social Psychiatry Research Institute
  • Social Psychiatry Research Institute
  • Midwest Clinical Research Center
  • University of Pittsburgh Medical Center
  • FutureSearch Trials
  • University of Texas, Health Science Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pagoclone

Placebo

Arm Description

.15mg, .30mg, .60mg

Placebo

Outcomes

Primary Outcome Measures

Effects of Pagaclone
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
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

Full Information

First Posted
September 16, 2005
Last Updated
August 27, 2012
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00216255
Brief Title
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Developmental Stuttering
Keywords
Persistent Developmental Stuttering

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pagoclone
Arm Type
Experimental
Arm Description
.15mg, .30mg, .60mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pagoclone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effects of Pagaclone
Description
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.
Time Frame
8 weeks double blind followed by a 52 weeks open label
Secondary Outcome Measure Information:
Title
Secondary Objectives
Description
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
Time Frame
Pre-treatment through week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
University of California, Irvine Medical School
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4788
Country
United States
Facility Name
Atlanta Institute of Medicine & Research-Atlanta Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Davis Clinic PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pivotal Research Centers
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Social Psychiatry Research Institute
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
University of Texas, Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stutteringstudy.com
Description
Related Info

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EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

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