EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Persistent Developmental Stuttering

In brief

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.

Key facts

Study ID

NCT00216255

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

120

Starts

2005-04-01

Expected to finish

2011-07-01

Last updated by the study team

2012-09-03

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, 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

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

• Pivotal Research Centers — Peoria, Arizona, United States
• University of California, Irvine Medical School — Orange, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Atlanta Institute of Medicine & Research-Atlanta Clinic — Atlanta, Georgia, United States
• Davis Clinic PC — Indianapolis, Indiana, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Pivotal Research Centers — Royal Oak, Michigan, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• Social Psychiatry Research Institute — New York, New York, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• FutureSearch Trials — Austin, Texas, United States
• University of Texas, Health Science Center — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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