CompletedPhase 2

Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)

United StatesStarted 2005-04

Plain-language 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 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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

Trial details

NCT IDNCT00239915

SponsorPharmacology Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Persistent Developmental Stuttering trials