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

This study is ongoing, but not recruiting participants.

First Received: October 13, 2005 Last Updated: April 13, 2006 History of Changes

Sponsored by:	Pharmacology Research Institute
Information provided by:	Pharmacology Research Institute
ClinicalTrials.gov Identifier:	NCT00239915

Purpose

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.

Condition	Intervention	Phase
Persistent Developmental Stuttering	Drug: Pagoclone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Stuttering

Drug Information available for: Pagoclone

U.S. FDA Resources

Further study details as provided by Pharmacology Research Institute:

Study Start Date:	April 2005
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239915

Locations

United States, California
Pharmacology Research Institute
Riverside, California, United States, 92506

Sponsors and Collaborators

Pharmacology Research Institute

Investigators

Principal Investigator:

Jon F. Heiser, M.D.

Pharmacology Research Institute

More Information

No publications provided

Study ID Numbers:	PRI#600
Study First Received:	October 13, 2005
Last Updated:	April 13, 2006
ClinicalTrials.gov Identifier:	NCT00239915 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Speech Disorders
Neurologic Manifestations
Language Disorders

Stuttering
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Speech Disorders
Nervous System Diseases
Neurologic Manifestations

Language Disorders
Stuttering
Neurobehavioral Manifestations
Communication Disorders

ClinicalTrials.gov processed this record on September 11, 2009