NCT01582854

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

A 12-month, International, Parallel Group, Randomised, Multi-centre, Double-blind, Placebo-controlled Trial to Examine the Effect of Actovegin® Treatment Given First Intravenously and Subsequently Orally Over 6 Months, in Subjects With Post-stroke Cognitive Impairment (PSCI).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

• Post-Stroke Cognitive Impairment (PSCI)

Interventions

Type	Name	Description
DRUG	Actovegin	Actovegin solution for infusion and Actovegin tablets
DRUG	Placebo	Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-04-23
• Last updated: 2016-02-22
• Results posted: 2016-02-22

Locations

14 sites across 3 countries: Belarus, Kazakhstan, Russia