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

Takeda

Status and phase: Completed; Phase 3

Conditions: Post-Stroke Cognitive Impairment (PSCI)

Treatments: Drug: Actovegin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582854

U1111-1132-3434 (Registry Identifier)

AV-2500-301-RD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 503 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Participant has suffered a recent supra-tentorial ischaemic stroke supported by computed tomography (CT) scan or magnetic resonance imaging (MRI) findings (in accordance 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 has a score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23 points, 10-12 years ≤ 24 points, >12 years ≤ 25 points).

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 the current standard of care.

Randomisation Criteria:

• Inclusion Criteria.
• Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+).
• Exclusion Criteria.
• Clinically there is suspicion of progressive stroke.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 2 patient groups, including a placebo group

Actovegin

Active Comparator group

Description:

Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.

Treatment:

Drug: Actovegin

Placebo

Placebo Comparator group

Description:

Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.

Treatment:

Drug: Placebo