An open-label, randomized controlled study evaluating the effectiveness of pramipexole extended-release tablets for tardive dystonia.
- Conditions
- Tardive dystonia
- Registration Number
- JPRN-UMIN000014988
- Lead Sponsor
- Department of Psychiatry, Chiba University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Not provided
1) With blepharospasm or oculogyric crisis alone as a symptom of tardive dystonia 2) Without a treatment history with anticholinergic agent 3) Under treatment with clozapine 4) With treatment histroy of deep brain stimulation (DBS) 5) With treatment history of electroconvulsove therapy (ECT) within 3 months prior to the study enrollment 6) With treatment history of botulinum toxin within 3 months prior to the study enrollment 7) Particition history of a clinical trial with any intervention ( i.e., except for observational study), within the most recent 3 months prior to the study enrollment 8) Without notification of a diagnosis of psychiatric disease 9) pregnant or childbearing-potential woman, and woman who are breast-feeding 10) With renal dysfunction: serum creatinine > 2.0 mg/dl 11) With hypersensitivity to any ingredient of the trial drug 12) With a suicide history within the most recent 1 year prior to the study enrollment 13) Assessed as unsuitable for participation in the study by the study physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Burke-Fahn-Marsden Dystonia Rating Scale
- Secondary Outcome Measures
Name Time Method Extrapyramidal Symptom Rating Scale(ESRS), Brief Psychiatric Rating Scale(BPRS), Euro Qol 5 demensions(EQ-5D)