Efficacy and Safety of Mildronate for Acute Ischemic Stroke

February 25, 2013 updated by: Xijing Hospital

Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The Department of Neurology , Xijing Hospital
        • Contact:
        • Principal Investigator:
          • Yi Zhu, MD
        • Principal Investigator:
          • Guang Yun Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mildronate
infusion of mildronate
Drug: infusion of mildronate
infusion of mildronate(500mg) once a day and for 14 days
Drug: aspirin
infusion of aspirin (100mg) once a day for days
Placebo Comparator: placebo
infusion of placebo mildronate
Drug: aspirin
infusion of aspirin (100mg) once a day for days
Drug: placebo
infusion of plabcebo once a day and for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the modified Rankin scale
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NIHSS scores
Time Frame: 8 days
8 days
NIHSS scores
Time Frame: 15 days
15 days
the Barthel index
Time Frame: 8 days
8 days
the Barthel index
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Yi Zhu, MD, The Department of Neurology , Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xijing-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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