EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Endo Pharmaceuticals120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Persistent Developmental Stuttering

Interventions

PagocloneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

Pivotal Research Centers

Peoria, Arizona, United States

University of California, Irvine Medical School

Orange, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks double blind followed by a 52 weeks open label

Secondary Outcomes

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

Time frame: Pre-treatment through week 8

Data from ClinicalTrials.gov

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