RecruitingPhase 3NCT07275749

Acetyl-leucine in Post-stroke Ataxia

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

Sponsor

Kafrelsheikh University

Enrollment

200 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

the investigators included both males and females, aged between 18 and 80 years, who experienced their first-ever posterior-circulation ischaemic stroke and presented with gait ataxia and score at least 1 point on the items gait, stance, trunk or heel-shin-slide of the Scale for the Assessment and Rating of Ataxia (SARA) and 47 points or less on the Berg Balance Scale (BBS).
All of our patients underwent randomisation during the first 24 hours of the symptoms' onset, and within the first 24 hours from the time at which the patient's condition was last reported to be normal for wake-up stroke patients.

Exclusion Criteria6

the investigators excluded patients with modified Rankin Scale (mRS) score of 5 or more, physical or mental conditions that would not allow safe participation in the study or would influence the assessment of outcomes (e.g., dementia, disturbed conscious level, severe aphasia, etc.).
the investigators ruled out participants who suffered from neurological diseases associated with recurrent neurological deficits, such as (epilepsy, multiple sclerosis, head trauma followed by neurological deficit).
the investigators excluded participants who underwent intravenous thrombolysis, carotid, cerebrovascular, or coronary revascularization during the first week of the trial to avoid clouding of efficacy and safety analysis.
the investigators excluded patients who experienced recurrent ischemic stroke detected from their clinical data and/or magnetic resonance imaging (MRI) brain findings. In addition, we excluded participants who experienced hypersensitivity to the study treatment
the investigators excluded participants who experienced organ failure such as renal failure and liver cell failure, active malignancies, and patients with a known bleeding diathesis or coagulation disorder, a history of intracerebral hemorrhage, gastrointestinal bleeding within the past 6 months, or major surgery within 30 days before randomisation .
the investigators excluded pregnant and lactating women, patients with cerebral venous thrombosis, and patients with stroke associated with cardiac arrest.

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Interventions

DRUGAcetyl-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.

DRUGPlacebo

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.

DRUGClopidogrel 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.

DRUGaspirin 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.