Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pharmacology Research Institute
ClinicalTrials.gov Identifier:
NCT00239915
First received: October 13, 2005
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
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

ClinicalTrials.gov Identifier: NCT00239915     History of Changes
Other Study ID Numbers: PRI#600
Study First Received: October 13, 2005
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013