Status:
COMPLETED
Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke
Lead Sponsor:
Materia Medica Holding
Conditions:
Mild Cognitive Impairment
Ischemic Stroke
Eligibility:
All Genders
45-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is: * to evaluate efficacy of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke * to evaluate safety of MMH...
Detailed Description
A double-blind, placebo-controlled randomized clinical trial in parallel groups. The study patients are subjects of either gender, aged 45-80 years old, after an ischemic stroke within 3-6 months pri...
Eligibility Criteria
Inclusion
- Patients of either sex, aged 45 to 80 years old inclusively.
- Patients with a history of one stroke sustained 3 to 6 months prior to study entry and confirmed by neuroimaging.
- Patients with cognitive impairment (MoCA score \< 26).
- Patients with moderate performance in activities of daily living (Barthel score = 61-80).
- Agreement to use a reliable method of birth control for the duration of the study (men and women of reproductive potential).
- Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Exclusion
- Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition which has caused neurological dysfunction.
- History of central nervous system (CNS) disorders, including:
- inflammatory diseases of the CNS (G00-G09)
- systemic atrophies primarily affecting the CNS (G10-G13)
- extrapyramidal and movement disorders (G20-G26)
- other degenerative diseases of the nervous system (G30-G32)
- demyelinating diseases of the CNS (G35-G37)
- epilepsy (G40-41)
- polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders
- diseases of neuromuscular junction and muscle (G70-73)
- hydrocephalus (G91)
- compression of brain (G93.5).
- Dementia (20 or less on the MMSE score).
- Speech disorders affecting investigator-patient communication.
- Prior diagnosis of heart failure defined by the New York Heart Association classification (1964) as IV Functional Classification or poorly treated hypothyroidism or diabetes mellitus.
- Patients having unstable angina or myocardial infarction in the past 6 months.
- History/suspicion of oncology of any location (except for benign neoplasms).
- Any other co-morbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
- Patients allergic to/intolerant of any components of the study treatment.
- Patients with hereditary lactose intolerance.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- Pregnancy, breast-feeding or unwillingness to use birth control during the study.
- Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.
- Patients with a history of non-adherence to medication; mental disorder (except for cognitive deficits); or alcoholism or abuse of psychoactive substances, which, in the investigator's opinion, will compromise compliance with study procedures.
- Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the past week.
- Participation in other clinical trials in the previous 3 months.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Key Trial Info
Start Date :
October 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT03815292
Start Date
October 19 2018
End Date
January 27 2020
Last Update
February 23 2021
Active Locations (28)
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1
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, Russia, 163045
2
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, Russia, 308007
3
Non-State Healthcare Institution "Divisional Hospital at the Bryansk-2 station of the open joint-stock company Russian Railways"
Bryansk, Russia, 241004
4
Bryansk Regional Hospital № 1
Bryansk, Russia, 241033