UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage
Title of the study (Brief title)	LEV-SAH
Region	Japan

Condition
Condition	Poor-grade subarachnoid hemorrhage
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of levetiracetam on overcoming neurological deterioration due to non-convulsive status epileptics or non-convulsive seizure occurring after aneurysmal subarachnoid hemorrhage
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Functional outcome using the Modified Rankin Scale dichotomized into good or poor at 6 months after the onset of subarachnoid hemorrhage
Key secondary outcomes	(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

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Levetiracetam group: Group B Levetiracetam at 3000mg/day (50% E Keppra dry syrup 3g at a time, b.i.d.)
Interventions/Control_2	Placebo group: Group A Levetiracetam at 0mg/day (lactose 3g at a time, b.i.d.)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	80

Research contact person
Name of lead principal investigator	Teiji Tominaga
Organization	Tohoku Graduate School of Medicine
Division name	Department of Neurosurgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7000
Email	tomi@nsg.med.tohoku.ac.jp

Public contact
Name of contact person	Kenichi Sato
Organization	Kohnan Hospital
Division name	Department of Neuroendovascular therapy
Address	4-20-1 Nagamachi-minami, Taihaku-ku, Sendai, 982-8523, Japan
TEL	022-248-2131
Homepage URL
Email	satoken0724@yahoo.co.jp

Sponsor
Institute	Department of Neurosurgery, Tohoku Graduate School of Medicine
Institute
Department

Funding Source
Organization	GONRYO for the promotion of Medical Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	一般財団法人広南会　広南病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 24 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 25 Day
Last modified on	2017 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015781