Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
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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 syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.
An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
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
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