OnabotulinumtoxinA in the Management of Psychogenic Dystonia

Completed · Phase 4 · Has a placebo group

Conditions studied: Torticollis, Dystonia

In brief

The purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

Key facts

Study ID

NCT02618889

Run by

University of Cincinnati

People needed

18

Starts

2016-01-15

Expected to finish

2017-06-30

Last updated by the study team

2018-11-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet standard criteria for clinically definite PsyD;17
• PsyD severity and disability score ≥ 10 as measured by the RSPMD (Appendix 1);10
• Dystonic posturing must have been present without remission for a period longer than 1 year.
• Between the ages of 18 and 75, inclusive

You may not qualify if…

• Prior treatment with any BoNT
• Presence of clinically unstable medical condition other than the condition under evaluation
• Concurrent participation in another investigational drug or device study within 30 days prior to study enrollment.
• We will also exclude subjects with medical disorders deemed at increased risk when exposed to BoNT, including myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or other neuromuscular disorders.

Where it is running

• Alberto Espay — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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