EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Persistent Developmental Stuttering

Treatments: Drug: Placebo; Drug: Pagoclone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00216255

IP456-039

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Pagoclone

Experimental group

Description:

.15mg, .30mg, .60mg

Treatment:

Drug: Pagoclone

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo