Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01582854 | Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI) | PHASE3 | COMPLETED | 503 | — | — | Jun 1, 2012 | Nov 1, 2014 | Feb 22, 2016 | 14 | Belarus, Kazakhstan +1 |
The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement. Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate.
| Arm | Type | Description |
|---|---|---|
| Actovegin | ACTIVE_COMPARATOR | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Actovegin | DRUG | Actovegin solution for infusion and Actovegin tablets |
| Placebo | DRUG | Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets |
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 sco...