| CTRI Number |
CTRI/2009/091/000309 [Registered on: 23/04/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EDARAVONE IN ACUTE ISCHEMIC STROKE |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFICACY OF EDARAVONE IN ACUTE ISCHEMIC STROKE |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Sharma |
| Designation |
|
| Affiliation |
|
| Address |
DEPARTMENT OF NEUROLOGY
CSM MEDICAL UNIVERSITY
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
drpawan_sharma@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF. RAKESH SHUKLA |
| Designation |
|
| Affiliation |
|
| Address |
DEPARTMENT OF NEUROLOGY
CSM MEDICAL UNIVERSITY
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
rakeshshukla_rakesh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF. RAKESH SHUKLA |
| Designation |
|
| Affiliation |
|
| Address |
DEPARTMENT OF NEUROLOGY
CSM MEDICAL UNIVERSITY
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
rakeshshukla_rakesh@rediffmail.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
NONE |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PROF. RAKESH SHUKLA |
DEPARTMENT OF NEUROLOGY |
DEPARTMENT OF NEUROLOGY,CSM MEDICAL UNIVERSITY-226003
Lucknow
UTTAR PRADESH |
05222257090
05222257090
rakeshshukla_rakesh@rediffmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, LUCKNOW |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ISCHEMIC STROKE, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EDARAVONE |
30 MG INFUSION BD FOR 2 WEEKS |
| Comparator Agent |
normal saline |
500 ml for 2 weeks |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Patients with acute ischemic stroke hospitalized between 6 and 72 hours of onset of stroke.
|
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| ExclusionCriteria |
| Details |
Patients with age less than 18 years, unclear time of onset, those who received any thrombolytic therapy, those with severe hepatic disease, renal dysfunction, pregnancy or lactating female. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Score |
90 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| All cause mortality |
90 days |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a prospective, open labeled, randomized controlled clinical trial to investigate the safety and efficacy of edaravone in terms of functional outcome in patients with acute ischemic stroke, that will be conducted in the Department of Neurology, CSM Medical University, Lucknow. the primary outcome will be modified Rankin Scale at 90 days. The secondary outcome will be all cause mortality at 90 days. |