Back to resultsEfficacy and Safety of Mildronate for Acute Ischemic Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
infusion of mildronate
placebo
aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring randomized trial, acute ischemic stroke, mildronate
Eligibility Criteria
Inclusion Criteria:
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Exclusion Criteria:
- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
Sites / Locations
- the Department of Neurology , Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mildronate
placebo
Arm Description
infusion of mildronate
infusion of placebo mildronate
Outcomes
Primary Outcome Measures
the modified Rankin scale
Secondary Outcome Measures
NIHSS scores
NIHSS scores
the Barthel index
the Barthel index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01800357
Brief Title
Efficacy and Safety of Mildronate for Acute Ischemic Stroke
Official Title
Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke
Detailed Description
a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
randomized trial, acute ischemic stroke, mildronate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mildronate
Arm Type
Experimental
Arm Description
infusion of mildronate
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
infusion of placebo mildronate
Intervention Type
Drug
Intervention Name(s)
infusion of mildronate
Intervention Description
infusion of mildronate(500mg) once a day and for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
infusion of plabcebo once a day and for 14 days
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
infusion of aspirin (100mg) once a day for days
Primary Outcome Measure Information:
Title
the modified Rankin scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NIHSS scores
Time Frame
8 days
Title
NIHSS scores
Time Frame
15 days
Title
the Barthel index
Time Frame
8 days
Title
the Barthel index
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Exclusion Criteria:
- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Zhao, MD
Phone
02984775361
Email
zhaogang@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Organizational Affiliation
the Department of Neurology , Xijing Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yi Zhu, MD
Organizational Affiliation
the Department of Neurology , Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
the Department of Neurology , Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Phone
02984775361
Email
zhaogang@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yi Zhu, MD
First Name & Middle Initial & Last Name & Degree
Guang Yun Zhang, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Mildronate for Acute Ischemic Stroke
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