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

Endo Pharmaceuticals321 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

321

Conditions

Stuttering

Interventions

pagocloneDRUG

0.30 mg BID, 0.60 mg BID

placeboOTHER

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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