Post-Stroke Cognitive Impairment (PSCI) Clinical Trial
Official title:
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).
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05976152 -
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
|
Phase 3 |