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

NCT01582854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2016-02-22

Study results available
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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.

Conditions

  • Post-Stroke Cognitive Impairment (PSCI)

Interventions

DRUG

Actovegin

Actovegin solution for infusion and Actovegin tablets

DRUG

Placebo

Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Belarus
  • Kazakhstan
  • Russia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582854 on ClinicalTrials.gov