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NCT07275749RecruitingPhase 3

Acetyl-leucine in Post-stroke Ataxia

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

Source: ClinicalTrials.gov · Last updated 10 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
200 (estimated)
First submitted
24 Nov 2025
Start date
1 Dec 2025
Primary completion date
1 Jul 2026
Lead sponsor
Kafrelsheikh University
Diseases
Stroke
NCT number
NCT07275749

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 200
  • From 1 Dec 2025 to the primary completion date, 1 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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.

Other illness

  • 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 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

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kafr-Elsheikh University Hospital
Coordinator of this site? Confirm its status
Kafr ash ShaykhEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.