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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2

Details

• Lead Sponsor: Pharmacology Research Institute

Criteria

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