NCT00830154

Brief Summary

A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

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

First Submitted

Initial submission to the registry

January 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

January 25, 2009

Last Update Submit

August 20, 2012

Conditions

Stuttering

Keywords

stutterstutteringAdults with a history of stuttering

Outcome Measures

Primary Outcomes (1)

  • To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo.

    Weeks 8, 16 and 24

Secondary Outcomes (1)

  • Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.

    24 weeks

Study Arms (3)

1

EXPERIMENTAL

0.30 mg pagoclone BID

Drug: pagoclone

2

EXPERIMENTAL

0.60 mg pagoclone BID

Drug: pagoclone

3

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

pagocloneDRUG

0.30 mg BID, 0.60 mg BID

12
placeboOTHER

placebo

3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
  • Stuttering severity must be notable for \> 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.

You may not qualify if:

  • Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Indianapolis, Indiana, United States

Location

Related Links

MeSH Terms

Conditions

Stuttering

Interventions

pagoclone

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2009

First Posted

January 27, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

US(1)