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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 13, 2005

Last Updated Date

April 13, 2006

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00239915 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Persistent Developmental Stuttering

Intervention ^†

Drug: Pagoclone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

December 2006

Primary Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00239915

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pharmacology Research Institute

Collaborators ^††

Investigators ^†

Principal Investigator:

Jon F. Heiser, M.D.

Pharmacology Research Institute

Information Provided By

Pharmacology Research Institute

Verification Date

April 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.