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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Stuttering

In brief

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

Key facts

Study ID

NCT00830154

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

321

Starts

2009-02-01

Expected to finish

2011-01-01

Last updated by the study team

2012-08-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.

Where it is running

• Study site — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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