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Completed

NCT Number: NCT00239915

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

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.

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Key information

Conditions

Persistent Developmental Stuttering

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pharmacology Research Institute

Riverside, California, 92506, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pagoclone

Drug

Sponsors and collaborators

Lead sponsor

Pharmacology Research Institute

Other

Registry information

Official study 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.

Important dates

Study start
2005
Study completion
2006
First posted
Oct 17, 2005
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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