Status:
COMPLETED
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Persistent Developmental Stuttering
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 stutte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00216255
Start Date
April 1 2005
End Date
July 1 2011
Last Update
September 3 2012
Active Locations (16)
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1
Pivotal Research Centers
Peoria, Arizona, United States, 85381
2
University of California, Irvine Medical School
Orange, California, United States, 92868
3
Pharmacology Research Institute
Riverside, California, United States, 92506
4
Pacific Clinical Research Medical Group
Upland, California, United States, 91786