Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage
Phase 2
- Conditions
- Poor-grade subarachnoid hemorrhage
- Registration Number
- JPRN-UMIN000013507
- Lead Sponsor
- Department of Neurosurgery, Tohoku Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1)A patient who had other neurological disorders before the onset, including epilepsy, cerebral infarction, intracerebral hemorrhage, intracranial tumor, traumatic or brain injury. 2)A patient with an expected survival of less than 1 year 3)A patient with serious renal disorder (eGFR < 40) 4)A patient with serious allergy/hypersensitivity to pyrrolidones 5)A patient whom the investigator considers to be ineligible as a subject
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome using the Modified Rankin Scale dichotomized into good or poor at 6 months after the onset of subarachnoid hemorrhage
- Secondary Outcome Measures
Name Time Method (1) Frequency of convulsion (2) Frequency of abnormal findings on electroencephalograph (3) Frequency of delayed cerebral ischemia and occurrence of performing endovascular therapy against cerebral vasospasm (4) Rate of brain atrophy at 6 months after the onset (5) Functional improvement using Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), and Barthel Index (BI) at 1 and 6 months after onset (6) Safety