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Tetrabenazine in hyperkinetic movement disorders of Wilson Disease

Efficacy and safety of adjunctive Tetrabenazine in neurological Wilson disease with hyperkinetic movement disorders: A double blind randomized placebo-controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077513
Enrollment
30
Registered
2024-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: G26- Extrapyramidal and movement disorders in diseases classified elsewhere

Interventions

Intervention1: Tetrabenazine: Tetrabenazine will be started in the dose of 12.5 mg twice daily for 1 week followed by 25 mg twice daily for 1 week, followed by 25 mg three times daily Control Interven

Sponsors

Professor Jayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients with newly or already diagnosed Wilson Disease having hyperkinetic disorders dystonia, chorea, tremor.

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 Wilson Disease will be excluded. Patient with hypokinetic disorders will also be excluded.

Design outcomes

Primary

MeasureTime frame
Improvement in BFMDRS, TMC score, TETRAS score by greater than 50% will be considered improved.Timepoint: At baseline and 12 weeks

Secondary

MeasureTime frame
Improvement in neurological severity scale, NPI & DOSS, UWRS, adverse effects. Neurophysiological improvement will be assessed by improvement in H-reflex and blink reflex. The difference in requirement of rescue medications in both the groups will be assessed.Timepoint: After 3 months

Countries

India

Contacts

Public ContactJayantee Kalita

Sanjay Gandhi Post Graduate Institute of medical Sciences

jayanteek@yahoo.com05222494177

Outcome results

None listed

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