Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI) (ARTEMIDA)
This study is currently recruiting participants.
Verified July 2012 by Takeda Global Research & Development Center, Inc.
Sponsor:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:
NCT01582854
First received: April 20, 2012
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
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 will receive IV infusions whilst in hospital, and tablets once discharged. Subjects will be followed up for a further six months after their treatment is stopped to explore if the cognitive symptoms of the subjects treated with Actovegin show sustained improvement. The trial will also explore the possible prevention of dementia with Actovegin in patients who have suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin will be collected.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Stroke Cognitive Impairment (PSCI) |
Drug: Actovegin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- ADAS-cog+ at 6 months (change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Alzheimer's Disease Assessment Scale + Cognitive subscale extended version) (ADAS-cog) measures cognitive performance by combining ratings of 11 items (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instruction, spoken language, word finding and comprehension)
Secondary Outcome Measures:
- ADAS-cog+ at 3 and 12 months (change from baseline) [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
- MoCA at end of infusion period, 3, 6 and 12 months (change from baseline) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Montreal Cognitive Assessment Scale (MoCA) measures a score of ≤ 25 points:
- 4-9 school years ≤ 23 points,
- 10-12 years ≤ 24 points
- >12 years ≤ 25 points
- ADAS-cog+ responders at time points 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
- Diagnosis of dementia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems (ICD-10) (Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research)
- NIHSS at end of infusion period, 3, 6 and 12 months (relative change from baseline) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]National Institutes of Health Stroke Scale (NIHSS) measures a score between 3 and 18.
- Barthel Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder.
- EuroQol EQ-5D (EQ-5D) at 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
The measurement of states of health is crucial in determining the outcomes of health care. The EuroQoL EQ-5D questionnaire was developed as a generic state of health measure and describes states of health in five dimensions: mobility, self care, usual activities, pain or discomfort, and anxiety or depression.
EQ-5D is a standardised measure of health status. 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression.
each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems
- Beck Depression Inventory, version II (BDI-II) at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
BDI II scale:
- 0-13 minimal depression
- 14-19 mild depression
- 20-28 moderate depression
- 29-63 severe depression
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Actovegin |
Drug: Actovegin
|
| Placebo Comparator: Placebo |
Drug: Placebo
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Subject has suffered a recent supra-tentorial ischaemic stroke supported by CT scan or MRI findings (in accordance with local practice).
- Subject is male or female, aged 60 years or above.
- Subject has a score on the National Institute of Health Stroke Scale (NIHSS) between 3 and 18 (inclusive)
- Subject 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:
- Subject has a medical history of dementia
- Subject has a known medical history of major depression or psychotic disorder
- Subject is indicated for treatment with thrombolytics or carotid surgery as the current standard of care
Randomisation Criteria
- Inclusion Criteria
- Ability to perform ADAS-cog+
- Exclusion Criteria
- Clinically there is suspicion of progressive stroke
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582854
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Belarus | |
| Nycomed Investigational Site | Recruiting |
| Grodno, Belarus | |
| Nycomed Investigational Site | Recruiting |
| Minsk, Belarus | |
| Nycomed Investigational Site | Recruiting |
| Vitebsk, Belarus | |
| Kazakhstan | |
| Nycomed Investigational Site | Recruiting |
| Almaty, Kazakhstan | |
| Russian Federation | |
| Nycomed Investigational Site | Not yet recruiting |
| Barnaul, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Ekaterinburg, Russian Federation | |
| Nycomed Investigational Site | Not yet recruiting |
| Irkutsk, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Kazan, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Krasnoyarsk, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Moscow, Russian Federation | |
| Nycomed Investigational Site | Not yet recruiting |
| Novosibirsk, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Samara, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| St. Petersburg, Russian Federation | |
| Nycomed Investigational Site | Recruiting |
| Tomsk, Russian Federation | |
Sponsors and Collaborators
Nycomed: A Takeda Company
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company ) |
| ClinicalTrials.gov Identifier: | NCT01582854 History of Changes |
| Other Study ID Numbers: | AV-2500-301-RD, U1111-1132-3434 |
| Study First Received: | April 20, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Belarus: Ministry of Health Kazakhstan: Ministry of Public Health Russia: Ministry of Health of the Russian Federation |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Post-Stroke Cognitive Impairment (PSCI) Stroke Actovegin Cognition disorders |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cognition Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Actovegin Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Radiation-Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013