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Efficacy and safety of levodopa in dystonia due to neurological Wilson disease, an open labeled placebo controlled randomized controlled trial

Efficacy and safety of levodopa in dystonia due to neurological Wilson disease, an open labeled placebo controlled randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062899
Enrollment
30
Registered
2024-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G248- Other dystonia

Interventions

Intervention1: Levodopa: Titration 2 weeks Levodopa and Carbidopa 10mg (1./2 tab tdsx 1 week and 1 tab tdsx 1week and half abs in less in 15 years and 2 tab tds 15 years of age Vs placebo Control Int

Sponsors

Dr Jayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Improvement in BFMDRS by 50% will be considered improvedTimepoint: 4 weeks and 12 weeks

Secondary

MeasureTime frame
Improvement in neurological severity scale, NPI & DOSS, UWRS, adverse effects.Timepoint: at 3 months

Countries

India

Contacts

Public ContactDr Jayantee Kalita

SGPGIMS Lucknow

jayanteek@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026