CompletedPhase 2

EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

United States120 participantsStarted 2005-04

Plain-language 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.

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, 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 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

What they're measuring

Effects of Pagaclone

Timeframe: 8 weeks double blind followed by a 52 weeks open label

Trial details

NCT IDNCT00216255

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

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