EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Study Overview
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Brief Summary
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The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.

Official Title
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An 8-week, Double-blind, Randomized, Multicenter, Flexible-dose, Placebo Controlled Pilot Study of Pagoclone in Patients With PDS Followed by a 52-week Open-label Extension

Conditions
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Persistent Developmental Stuttering

Intervention / Treatment
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* Drug: Pagoclone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PDS defined as DSM-IV-TR criteria, symptoms starting before age 8, and a total overall score of 18-36 on the SSI-3 English-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance Not pregnant or breastfeeding Able to consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pagoclone<br>.15mg, .30mg, .60mg | Drug: Pagoclone<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Pagaclone | Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore, the Subjective Screening of Stuttering (SSS) Severity Subscore, and the treatment and week 8 visits. All efficacy assessments will evaluate change from pre-treatment to each on-treatment week. | 8 weeks double blind followed by a 52 weeks open label | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objectives | SSI-3 Total overall Score and individual subscores (including frequency, duration, and physical concomitant subscores) Subjective Screening of Stuttering (SSS) test Speech Naturalness Scales (SNS) Liebowitz Social Anxiety Scale (LSAS) Stuttering Clinician's Global Impression-Improvement (CGI) Optional Neuropsychological Test Optional Functional Brain Imaging | Pre-treatment through week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Developmental Stuttering