EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
- Conditions
- Persistent Developmental Stuttering
- Interventions
- Drug: Placebo
- Registration Number
- NCT00216255
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pagoclone Pagoclone .15mg, .30mg, .60mg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Effects of Pagaclone 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
Name Time Method Secondary Objectives 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
Trial Locations
- Locations (14)
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Pivotal Research Centers
🇺🇸Royal Oak, Michigan, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Social Psychiatry Research Institute
🇺🇸New York City, New York, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Davis Clinic PC
🇺🇸Indianapolis, Indiana, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
University of California, Irvine Medical School
🇺🇸Orange, California, United States
Atlanta Institute of Medicine & Research-Atlanta Clinic
🇺🇸Atlanta, Georgia, United States
University of South Florida College of Medicine
🇺🇸Tampa, Florida, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
University of Texas, Health Science Center
🇺🇸San Antonio, Texas, United States