Persistent Developmental Stuttering
Conditions
Keywords
Persistent Developmental Stuttering
Brief summary
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.
Interventions
DRUGPagoclone
DRUGPlacebo
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Pagaclone | 8 weeks double blind followed by a 52 weeks open label | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objectives | Pre-treatment through week 8 | 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 |
Countries
United States
Outcome results
None listed