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

Persistent Developmental Stuttering Clinical Trial

Official title:

An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239915
• Other study ID #: PRI#600
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2005
• Last updated: May 8, 2012
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2012
• Source: Pharmacology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Developmental Stuttering
• Stuttering

Intervention

Drug:
• Pagoclone

Locations

Country	Name	City	State
United States	Pharmacology Research Institute	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacology Research Institute

Country where clinical trial is conducted

United States,