Status:
COMPLETED
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
Lead Sponsor:
Pharmacology Research Institute
Conditions:
Persistent Developmental Stuttering
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllab...
Eligibility Criteria
Inclusion
- PDS defined as DSM-IV-TR criteria
- Symptoms starting before age 8
- Total overall score of 18-36 on the SSI-3
- English speaking, with an 8th grade education
- Able to understand and cooperate with study requirements with assistance
- Not pregnant or breastfeeding
- Able to provide 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
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00239915
Start Date
April 1 2005
End Date
December 1 2006
Last Update
May 9 2012
Active Locations (1)
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1
Pharmacology Research Institute
Riverside, California, United States, 92506