Study of Efficacy and Safety of MEXIDOL®
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|ClinicalTrials.gov Identifier: NCT02793687|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: MEXIDOL® (ethylmethylhydroxypyridine succinate) Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of the Drug MEXIDOL® for a Long Sequence of Therapy in Patients With Hemispheric Ischemic Stroke in the Acute and Early Recovery Period|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2016|
Sequential therapy with MEXIDOL® as follows: MEXIDOL® (i.v. solution) - 500 mg / day. for 10 days, followed by application MEXIDOL® 1 tablet of 125 mg three times a day (daily dose 375 mg) for 8 weeks.
The use of the study drug is held with basic therapy.
Drug: MEXIDOL® (ethylmethylhydroxypyridine succinate)
Placebo Comparator: Placebo
Sequential therapy as follows: Placebo (i.v. solution) for 10 days followed by placebo 1 tablet three times a day for 8 weeks.
The use of a placebo is held with basic therapy.
- modified Rankin Scale [ Time Frame: 5 times during 67-71 days of the treatment ]
- The National Institutes of Health Stroke Scale [ Time Frame: 5 times during 67-71 days of the treatment ]
- Barthel Index [ Time Frame: 5 times during 67-71 days of the treatment ]
- Beck Depression Inventory [ Time Frame: 5 times during 67-71 days of the treatment ]
- EuroQoL Quality of Life Scale [ Time Frame: 5 times during 67-71 days of the treatment ]