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

Last updated: January 23, 2016
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Stroke

Memory Problems

Dementia

Treatment

N/A

Clinical Study ID

NCT01582854
AV-2500-301-RD
U1111-1132-3434
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Participant has suffered a recent supra-tentorial ischaemic stroke supported bycomputed tomography (CT) scan or magnetic resonance imaging (MRI) findings (inaccordance with local practice).

  • Participant is male or female, aged 60 years or above.

  • Participant has a score on the National Institute of Health Stroke Scale (NIHSS)between 3 and 18 (inclusive).

  • Participant is capable of completing the Montreal Cognitive Assessment (MoCA) and hasa score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23points, 10-12 years ≤ 24 points, >12 years ≤ 25 points).

Exclusion

Main Exclusion Criteria:

  • Participant has a medical history of dementia.

  • Participant has a known medical history of major depression or psychotic disorder.

  • Participant is indicated for treatment with thrombolytics or carotid surgery as thecurrent standard of care. Randomisation Criteria:

  • Inclusion Criteria.

  • Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale ExtendedVersion (ADAS-cog+).

  • Exclusion Criteria.

  • Clinically there is suspicion of progressive stroke.

Study Design

Total Participants: 503
Study Start date:
June 01, 2012
Estimated Completion Date:
November 30, 2014

Study 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.

Connect with a study center

  • Nycomed Investigational Site

    Grodno,
    Belarus

    Site Not Available

  • Nycomed Investigational Site

    Minsk,
    Belarus

    Site Not Available

  • Nycomed Investigational Site

    Vitebsk,
    Belarus

    Site Not Available

  • Nycomed Investigational Site

    Almaty,
    Kazakhstan

    Site Not Available

  • Nycomed Investigational Site

    Barnaul,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Irkutsk,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Kazan,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Samara,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Nycomed Investigational Site

    Tomsk,
    Russian Federation

    Site Not Available

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