EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
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
1 other identifier
interventional
120
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 3, 2012
August 1, 2012
6.3 years
September 16, 2005
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Secondary Objectives
Pre-treatment through week 8
Study Arms (2)
Pagoclone
EXPERIMENTAL.15mg, .30mg, .60mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
University of California, Irvine Medical School
Orange, California, 92868, United States
Pharmacology Research Institute
Riverside, California, 92506, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
University of South Florida College of Medicine
Tampa, Florida, 33613-4788, United States
Atlanta Institute of Medicine & Research-Atlanta Clinic
Atlanta, Georgia, 30328, United States
Davis Clinic PC
Indianapolis, Indiana, 46202, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66211, United States
Pivotal Research Centers
Royal Oak, Michigan, 48073, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Social Psychiatry Research Institute
New York, New York, 10021, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
FutureSearch Trials
Austin, Texas, 78756, United States
University of Texas, Health Science Center
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Related Links
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
April 1, 2005
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 3, 2012
Record last verified: 2012-08