EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals

Criteria

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