Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI) "ARTEMIDA"

Completed

Phase 3 Results

Trial Description

The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in subjects with post stroke cognitive impairment (PSCI) during a six month treatment period compared to subjects administered placebo. Subjects received IV infusions whilst in hospital, and tablets once discharged. Subjects were followed up for a further six months after their treatment had been stopped to explore if the cognitive symptoms of the subjects treated with Actovegin showed sustained improvement. The trial also explored the possible prevention of dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was collected.

Detailed Description

The drug tested in this study is called actovegin. Actovegin was tested to treat people who have post stroke cognitive impairment. This study looked at the improvement of cognitive symptoms in people who take actovegin compared to placebo.
The study enrolled 503 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which remained undisclosed to the patient and study doctor during the study:
- Actovegin-2000 mg intravenous solution; 2- 200 mg tablets 3 times a day
- Placebo intravenous solution; tablets (dummy inactive) - this is a solution or tablet that looks like the study drug but has no active ingredient
All participants received daily intravenous infusions in the hospital (up to a maximum of 20 infusions) followed by 2-200 mg tablets three times a day for the remainder of the 6-month treatment period.
This multi-centre trial was conducted in Belarus, Kazakhstan and Russia. The overall time to participate in this study was 12 months. Participants made multiple visits to the clinic plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets
    ARM 1: Kind: Experimental
    Label: Placebo
  • Actovegin Drug
    Intervention Desc: Actovegin solution for infusion and Actovegin tablets
    ARM 1: Kind: Experimental
    Label: Actovegin

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary ADAS-cog+ at 6 months (change from baseline) 6 months No
Secondary ADAS-cog+ at 3 and 12 months (change from baseline) 3 and 12 months No
Secondary MoCA at end of infusion period, 3, 6 and 12 months (change from baseline) 3, 6 and 12 months No
Secondary ADAS-cog+ responders at time points 3, 6 and 12 months 3, 6 and 12 months No
Secondary Diagnosis of dementia 6 and 12 months No
Secondary NIHSS at end of infusion period, 3, 6 and 12 months (relative change from baseline) 3, 6 and 12 months No
Secondary Barthel Index at 6 months 6 months No
Secondary EuroQol EQ-5D (EQ-5D) at 6 and 12 months 6 and 12 months No
Secondary Beck Depression Inventory, version II (BDI-II) at 3, 6 and 12 months 3, 6 and 12 months No
Primary Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6 Baseline and Month 6 No
Secondary Change From Baseline in ADAS-cog+ at Month 3 and Month 12 Baseline and Months 3 and 12 No
Secondary Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 Baseline, End of Infusion and Months 3, 6 and 12 No
Secondary Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months Baseline and Months 3, 6 and 12 No
Secondary Percentage of Participants With a Diagnosis of Dementia Month 6 No
Secondary Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12 Baseline and End of Infusion and Months 3, 6 and 12 No
Secondary Barthel Index at Months 3 and 6 Months 3 and 6 No
Secondary EuroQol EQ-5D (EQ-5D) at Month 6 Month 6 No
Secondary EuroQol EQ-5D (EQ-5D) at Month 12 Month 12 No
Secondary EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12 Months 6 and 12 No
Secondary Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12 Months 3, 6 and 12 No

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