Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT07275749

Acetyl-leucine in Post-stroke Ataxia

Led by Kafrelsheikh University · Updated on 2025-12-10

200

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Acetyl-leucine in Post-stroke Ataxia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 80 years
  • First-ever posterior-circulation ischemic stroke
  • Presenting with gait ataxia
  • Score at least 1 point on gait, stance, trunk, or heel-shin-slide items of the Scale for the Assessment and Rating of Ataxia (SARA)
  • Score 47 points or less on the Berg Balance Scale (BBS)
  • Randomization within 24 hours of stroke symptom onset or from last known normal for wake-up stroke patients
Not Eligible

You will not qualify if you...

  • Modified Rankin Scale (mRS) score of 5 or higher
  • Physical or mental conditions preventing safe participation or affecting outcome assessments (e.g., dementia, disturbed consciousness, severe aphasia)
  • History of neurological diseases with recurrent deficits (e.g., epilepsy, multiple sclerosis, head trauma with lasting problems)
  • Intravenous thrombolysis or revascularization procedures during the first week of trial
  • Recurrent ischemic stroke based on clinical or MRI findings
  • Hypersensitivity to study treatment
  • Organ failure (renal or liver failure), active cancer
  • Known bleeding disorders, recent intracerebral hemorrhage, gastrointestinal bleeding within 6 months, or major surgery within 30 days before randomization
  • Pregnant or breastfeeding women
  • Cerebral venous thrombosis
  • Stroke associated with cardiac arrest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt, 33511

Actively Recruiting

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Research Team

M

Mohamed G. Zeinhom, MD

CONTACT

S

Sherihan rezk Ahmed, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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