NCT07275749

Acetyl-leucine in Post-stroke Ataxia

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

the investigators will conduct our double-blinded, placebo-controlled, parallel-group trial in Kafr-Elsheikh University in the time between 1st January 2026 to 1st July 2026. the study will include 200 post-circulation AIS patients who will undergo randomization and divided into two groups; The (A) group, which consisted of 100 patients who administered (a 4 gram of acetyl-leucine per day) and the (B) group, which had 100 patients who administered a placebo during the first 24 hours of stroke onset and for 3 months. Both groups received (open-label 300 mg loading dose aspirin and 300 mg loading clopidogrel during the first 24 hours of stroke onset, followed by 75 mg clopidogrel and 100 mg aspirin once daily from the 2nd to the 90th day. The diagnosis of ischemic stroke was established through a detailed clinical history and examination and suitable brain imaging. All of the patients had CT of the brain and CT angiography (CTA) including the aortic arch through the circle of Willis before thrombolysis; the CT of the brain was performed on the 64-slice dual-source spiral CT scanner of Somatom definition by Siemens, and the supratentorial compartment scans were imaged with 5-8mm contiguous sections and the brain stem and cerebellum scans were imaged with 3-5mm slices, and we obtained eighteen images for each series. After thrombolysis, all of the patients underwent an MRI brain on a 1.5 T (Siemens Essenza) MR system, stroke protocol: T1W, T2W, fluid attenuation inversion recovery imaging (FLAIR), diffusion-weighted imaging (DWI), T2 Echo Gradient, and MRA brain \& neck time of flight (TOF) if CTA was contraindicated; the investigators performed an additional brain CT scan after 24-36 hours to evaluate hemorrhagic transformation. (8), and considered hemorrhagic transformation symptomatic if the NIHSS score increased by 4 points or more. (9) The computed tomography (CT)/ magnetic resonance imaging (MRI) examinations were assessed in our study by two highly experienced professionals: a senior stroke physician and a senior radiologist. the investigators identified posterior-circulation stroke (PCS) when ischemic occlusion affected basilar, posterior cerebral or vertebral arteries

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-07-01
• Completion: 2026-07-20
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: Egypt