Efficacy and safety of levodopa in dystonia due to neurological Wilson disease, an open labeled placebo controlled randomized controlled trial
Not Applicable
- Conditions
- Health Condition 1: G248- Other dystonia
- Registration Number
- CTRI/2024/02/062899
- Lead Sponsor
- Dr Jayantee Kalita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Baseline 4 weeks. Age more than 8 years, BFMDR score more than 10. Baseline blood investigation followed by 1: 1 randomization. Levodopa Titration for 2 weeks and maintained for 12 weeks
Exclusion Criteria
Patients with head injury, stroke, tumor, malignancy, chronic renal failure, decompensated liver disease, perinatal hypoxia, HIV, organ transplantation, pregnancy and those receiving antipsychotics, corticosteroid, antiemetic and structural brain lesion on MRI not explainable by WD will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in BFMDRS by 50% will be considered improvedTimepoint: 4 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method Improvement in neurological severity scale, NPI & DOSS, UWRS, adverse effects.Timepoint: at 3 months