MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial
Early Phase 1
Completed
- Conditions
- Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest
- Interventions
- Drug: Placebo
- Registration Number
- NCT05621590
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months.
We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation.
Exclusion Criteria
- pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mlc-901 group MLC 901 - placebo group Placebo -
- Primary Outcome Measures
Name Time Method neurofunctional outcome using Glasgow Outcome Scale (GOS) 6 months neurofunctional outcome using modified Rankin Scale (mRS) 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shahid Beheshti University of Medical Sciences, Shohada Hospital
🇮🇷Tehran, Iran, Islamic Republic of