EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Persistent Developmental Stuttering Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216255
• Other study ID #: IP456-039
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: August 27, 2012
• Start date: April 2005
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Developmental Stuttering
• Stuttering

Intervention

Drug:
• Pagoclone

• Placebo

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine & Research-Atlanta Clinic	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Davis Clinic PC	Indianapolis	Indiana
United States	Social Psychiatry Research Institute	New York City	New York
United States	University of California, Irvine Medical School	Orange	California
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Pivotal Research Centers	Peoria	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Pharmacology Research Institute	Riverside	California
United States	Pivotal Research Centers	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas, Health Science Center	San Antonio	Texas
United States	University of South Florida College of Medicine	Tampa	Florida
United States	Pacific Clinical Research Medical Group	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks double blind followed by a 52 weeks open label	Yes
Secondary	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	Pre-treatment through week 8	No

External Links

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