Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage

Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage - LEV-SAH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013507

Enrollment

Registered

2014-04-01

Start date

2014-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor-grade subarachnoid hemorrhage

Interventions

Levetiracetam group: Group B Levetiracetam at 3000mg/day (50% E Keppra dry syrup 3g at a time, b.i.d.) Placebo group: Group A Levetiracetam at 0mg/day (lactose 3g at a time, b.i.d.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A patient with aneurysmal subarachnoid hemorrhage accompanied by impaired consciousness (the World Federation of Neurologic Surgeons (WFNS) grading score II - V) 2) A patient with ruptured aneurysms secured within 72 hours after the onset 3) Age 20-80 years 4) A patient being independent before the onset 5) A patient who has provided written informed consent to participate in this study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Functional outcome using the Modified Rankin Scale dichotomized into good or poor at 6 months after the onset of subarachnoid hemorrhage	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactKenichi Sato

Kohnan Hospital Department of Neuroendovascular therapy

satoken0724@yahoo.co.jp022-248-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026