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

Endo Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stuttering

Treatments: Drug: pagoclone; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830154

IP456-041

Details and patient eligibility

About

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

Full description

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.

Enrollment: 321 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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321 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

0.30 mg pagoclone BID

Treatment:

Drug: pagoclone

2

Experimental group

Description:

0.60 mg pagoclone BID

Treatment:

Drug: pagoclone

3

Placebo Comparator group

Description:

placebo

Treatment:

Other: placebo