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

Completed · Phase 2

Conditions studied: Persistent Developmental Stuttering

In brief

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.

Key facts

Study ID

NCT00239915

Run by

Pharmacology Research Institute

Starts

2005-04-01

Expected to finish

2006-12-01

Last updated by the study team

2012-05-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pharmacology Research Institute — Riverside, California, United States

Full record on ClinicalTrials.gov

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