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

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ClinicalTrials.gov Identifier: NCT00239915
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : May 9, 2012
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Persistent Developmental Stuttering Drug: Pagoclone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : April 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00239915     History of Changes
Other Study ID Numbers: PRI#600
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

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