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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239915

Enrollment

Unknown

Registered

2005-10-17

Start date

2005-04-30

Completion date

2006-12-31

Last updated

2012-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Developmental Stuttering

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.

Interventions

DRUGPagoclone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026