Cytoflavin in the Complex Rehabilitation of Stroke Patients (NCT05935787) | Clinical Trial Compass
CompletedPhase 3
Cytoflavin in the Complex Rehabilitation of Stroke Patients
Russia240 participantsStarted 2023-06-30
Plain-language summary
It is known that the acute period of stroke occurs is accompanied by oxidative stress, when intense generation of reactive oxygen species (ROS) have a toxic effect, which causes oxidative degradation of proteins, lipids, nucleic acids. Antioxidants may have a positive effect on the processes of reparation, remodeling and neuroplasticity, thus improving the effectiveness of post-stroke rehabilitation. The adjunctive use of drug therapy that improves neuroplasticity may promote accelerated motor learning, which underlies the effects of exercise therapy and physical therapy, speech therapy, and sessions with a psychologist or occupational therapist. CYTOFLAVIN® is a combination of succinic acid, riboflavin, nicotinamide and inosine (riboxin) which has antihypoxic and antioxidant effects. The study hypothetizes that this neurometabolic drug will facilitate learning in stroke survivors and help to acquire new cognitive or motor skills necessary for daily living. The study will be conducted in two parallel groups of stroke survivors: the experimental group will be treated with Cytoflavin along with ohysical rehabilitation, the control group will receive standard rehabilitation course.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Signed Patient informed consent form
✓. Men and women aged 40 to 80, inclusive.
✓. Ischemic stroke in the carotid area, or hemorrhagic stroke in the cerebral hemispheres, occurred in the previous 14-90 days before screening.
✓. Acute neuroimaging data (CT and/or MRI) do not contradict the clinical and topical diagnosis of stroke.
✓. The presence of a measurable neurological deficit in the motor or sensory area.
✓. Availability of rehabilitation potential, which is assessed by the specialists of the multidisciplinary team
✓. Modified Rankin score 3-4.
✓. The possibility to visit outpatient rehabilitation at the research center.
Exclusion criteria
✕. Known hypersensitivity to any component of the study drug
✕
What they're measuring
1
Change of performance
Timeframe: 40 days
Trial details
NCT IDNCT05935787
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
. Severe visual and hearing impairments that prevent the implementation of study procedures.
✕. Severe spasticity (scored 3-4 by Ashworth scale).
✕. Impaired swallowing, which does not allow taking drugs orally.
✕. Communication deficit that does not allow the patient to fulfill the conditions of the study protocol (including total aphasia).
✕. The presence of contraindications to complex rehabilitation in a hospital (lack of rehabilitation potential, somatic diseases that prevent a complex of rehabilitation measures).
✕. Aneurysmal subarachnoid hemorrhage.
✕. Previous (before the actual ictus) stroke with residual neurological deficit.