Clinical trial NCT05935787: Cytoflavin in the Complex Rehabilitation of Stroke Patients
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Study of the Efficacy and Safety of Sequential Therapy With CYTOFLAVIN® (NTFF POLYSAN, Russia), Solution for Intravenous Infusion and Enteric-coated Tablets, in the Complex Rehabilitation of Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Stroke
Keywords: stroke rehabilitation
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 196
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Signed Patient informed consent form
2. Men and women aged 40 to 80, inclusive.
3. Ischemic stroke in the carotid area, or hemorrhagic stroke in the cerebral hemispheres, occurred in the previous 14-90 days before screening.
4. Acute neuroimaging data (CT and/or MRI) do not contradict the clinical and topical diagnosis of stroke.
5. The presence of a measurable neurological deficit in the motor or sensory area.
6. Availability of rehabilitation potential, which is assessed by the specialists of the multidisciplinary team
7. Modified Rankin score 3-4.
8. The possibility to visit outpatient rehabilitation at the research center.
9. Ability to understand and comply with protocol requirements.
10. For women: consent to use reliable methods of contraception or absent reproductive potential.
11. For men: consent to the use of adequate methods of contraception, or complete abstinence from sexual activity for the period of the study, or absent reproductive potential.

Exclusion Criteria:

1. Known hypersensitivity to any component of the study drug
2. Severe visual and hearing impairments that prevent the implementation of study procedures.
3. Severe spasticity (scored 3-4 by Ashworth scale).
4. Impaired swallowing, which does not allow taking drugs orally.
5. Communication deficit that does not allow the patient to fulfill the conditions of the study protocol (including total aphasia).
6. The presence of contraindications to complex rehabilitation in a hospital (lack of rehabilitation potential, somatic diseases that prevent a complex of rehabilitation measures).
7. Aneurysmal subarachnoid hemorrhage.
8. Previous (before the actual ictus) stroke with residual neurological deficit.
9. Disability is primarily not attributed to the last stroke
10. Severe renal failure
11. Severe liver failure
12. End stage of other chronic incurable diseases.
13. Decompensated diabetes mellitus.
14. History of cancer, mental illness, HIV infection, syphilis, tuberculosis, alcohol, drug or drug addiction.
15. Established diagnosis of a mental or neurodegenerative disease
16. Constant use of psychotropic drugs (neuroleptics, tranquilizers, antidepressants) or nootropic drugs in the previous 3 months before the patient was included in the study, except for stroke treatment in acute hospital.
17. Alcohol or drug addiction

19. Pregnancy, lactation.

Primary outcomes:
measure: Change of performance
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: City General Hospital №2
city: Saint Petersburg
country: Russian Federation
facility: City Hospital №40 of the Kurortny District
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Study officials:
affiliation: First St. Petersburg State Medical University named after I.P. Pavlov
name: Alexey Shmonin, Prof
role: STUDY_DIRECTOR
References: