Study of Efficacy and Safety of MEXIDOL®

Completed

Phase 3 Results N/A

Trial Description

A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group study in patients with stroke

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: 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.
  • MEXIDOL® (ethylmethylhydroxypyridine succinate) Drug
    ARM 1: Kind: Experimental
    Label: Mexidol
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale 5 times during 67-71 days of the treatment No
Secondary The National Institutes of Health Stroke Scale 5 times during 67-71 days of the treatment No
Secondary Barthel Index 5 times during 67-71 days of the treatment No
Secondary Beck Depression Inventory 5 times during 67-71 days of the treatment No
Secondary EuroQoL Quality of Life Scale 5 times during 67-71 days of the treatment No

Sponsors