UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013507 |
|---|---|
| Receipt number | 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 10:11:51 |
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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
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
satoken0724@yahoo.co.jp
Sponsor or person
Institute
Department of Neurosurgery, Tohoku Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015781
