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

NCT ID: NCT00830154

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stuttering

Keywords

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stutter stuttering Adults with a history of stuttering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

0.30 mg pagoclone BID

Group Type EXPERIMENTAL

pagoclone

Intervention Type DRUG

0.30 mg BID, 0.60 mg BID

2

0.60 mg pagoclone BID

Group Type EXPERIMENTAL

pagoclone

Intervention Type DRUG

0.30 mg BID, 0.60 mg BID

3

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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pagoclone

0.30 mg BID, 0.60 mg BID

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Indianapolis, Indiana, United States

Site Status

Countries

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United States

Related Links

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http://www.stutteringstudy.com

Click here for more information about this study

Other Identifiers

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IP456-041

Identifier Type: -

Identifier Source: org_study_id