Efficacy and Safety of Mildronate for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01800357
• Other study ID #: xijing-007
• Status: Recruiting
• Phase: Phase 2
• First received: February 25, 2013
• Last updated: February 25, 2013
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2013
• Source: Xijing Hospital
• Contact: Gang Zhao, MD
• Phone: 02984775361
• Email: zhaogang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• infusion of mildronate
infusion of mildronate(500mg) once a day and for 14 days
• placebo
infusion of plabcebo once a day and for 14 days
• aspirin
infusion of aspirin (100mg) once a day for days

Locations

Country	Name	City	State
China	the Department of Neurology , Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the modified Rankin scale		3 months	No
Secondary	NIHSS scores		8 days	No
Secondary	NIHSS scores		15 days	No
Secondary	the Barthel index		8 days	No
Secondary	the Barthel index		15 days	No