NCT00239915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

First QC Date

October 13, 2005

Last Update Submit

May 8, 2012

Conditions

Persistent Developmental Stuttering

Interventions

PagocloneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacology Research Institute

Riverside, California, 92506, United States

Location

MeSH Terms

Interventions

pagoclone

Study Officials

  • Jon F. Heiser, M.D.

    Pharmacology Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

April 1, 2005

Study Completion

December 1, 2006

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(1)