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

Pharmacology Research Institute

Status and phase

Completed

Phase 2

Conditions

Persistent Developmental Stuttering

Treatments

Drug: Pagoclone

Study type

Interventional

Funder types

Other

Identifiers

NCT00239915

PRI#600

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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