NCT07275749 Acetyl-leucine in Post-stroke Ataxia
| NCT ID | NCT07275749 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kafrelsheikh University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-07-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
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