Clinical trial NCT00216255: EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
Official title: An 8-week, Double-blind, Randomized, Multicenter, Flexible-dose, Placebo Controlled Pilot Study of Pagoclone in Patients With PDS Followed by a 52-week Open-label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Developmental Stuttering
Keywords: Persistent Developmental Stuttering
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Effects of Pagaclone
timeFrame: 8 weeks double blind followed by a 52 weeks open label
Secondary outcomes:
measure: Secondary Objectives
timeFrame: Pre-treatment through week 8
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Orange
country: United States
facility: University of California, Irvine Medical School
state: California
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research-Atlanta Clinic
state: Georgia
city: Indianapolis
country: United States
facility: Davis Clinic PC
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Royal Oak
country: United States
facility: Pivotal Research Centers
state: Michigan
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York City
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: San Antonio
country: United States
facility: University of Texas, Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: