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A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

Primary Purpose

Stuttering

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pagoclone

placebo

About this trial

This is an interventional treatment trial for Stuttering focused on measuring stutter, stuttering, Adults with a history of stuttering

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

0.30 mg pagoclone BID

0.60 mg pagoclone BID

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00830154

First Posted

January 25, 2009

Last Updated

August 20, 2012

Sponsor

Endo Pharmaceuticals

Collaborators

Teva Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT00830154

Brief Title

A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

Official Title

A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endo Pharmaceuticals

Collaborators

Teva Pharmaceuticals USA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stuttering

Keywords

stutter, stuttering, Adults with a history of stuttering

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

321 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

0.30 mg pagoclone BID

Arm Title

Arm Type

Experimental

Arm Description

0.60 mg pagoclone BID

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

pagoclone

Intervention Description

0.30 mg BID, 0.60 mg BID

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

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.

Time Frame

Weeks 8, 16 and 24

Secondary Outcome Measure Information:

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.

Facility Information:

City

Indianapolis

State/Province

Indiana

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.stutteringstudy.com

Description

Click here for more information about this study

Learn more about this trial

A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

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