Back to resultsSafety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
Primary Purpose
Persistent Developmental Stuttering
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pagoclone
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Developmental Stuttering
Eligibility 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
Sites / Locations
- Pharmacology Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00239915
First Posted
October 13, 2005
Last Updated
May 8, 2012
Sponsor
Pharmacology Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00239915
Brief Title
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacology Research Institute
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Developmental Stuttering
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pagoclone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon F. Heiser, M.D.
Organizational Affiliation
Pharmacology Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
We'll reach out to this number within 24 hrs