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RECRUITING
NCT07275749
PHASE3

Acetyl-leucine in Post-stroke Ataxia

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

Along with the current clinical trial, the efficacy and safety of 4 gram of acetyl-leucine daily for three months in patients with post-stroke ataxia following posterior-circulation ischaemic stroke assessed through BBS, SARA, and mRS, and possible adverse effects.

Official title: The Safety and Efficacy of Acetyl-leucine in Post-stroke Ataxia: a Randomized Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-12-01

Completion Date

2026-07-20

Last Updated

2025-12-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Acetyl-Leucine

The acetyl-leucine arm will receive (a 4 gram of acetyl-leucine daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.

DRUG

Placebo

The placebo arm will receive (a 4 gram of placebo daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.

DRUG

Clopidogrel 75 Mg Oral Tablet

All patients received an open-label loading 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 75 mg clopidogrel once daily.

DRUG

aspirin 100mg

All patients received an open-label loading 300 mg aspirin during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin once daily.

Locations (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt