UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013507
Receipt No. R000015781
Scientific Title Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage
Date of disclosure of the study information 2014/04/01
Last modified on 2017/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage
Acronym LEV-SAH
Scientific Title Randomized, double-blind, placebo-controlled study to evaluate the efficacy of levetiracetam on overcoming neurological deterioration occurring in patients with poor-grade subarachnoid hemorrhage
Scientific Title:Acronym 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
1st name
Middle name
Last name Teiji Tominaga
Organization Tohoku Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
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
1st name
Middle name
Last name Kenichi Sato
Organization Kohnan Hospital
Division name Department of Neuroendovascular therapy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 24 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.