Cytoflavin in the Complex Rehabilitation of Stroke Patients

Last updated: December 11, 2024
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Recruiting

Phase

3

Condition

Cerebral Ischemia

Stroke

Treatment

Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)

Placebo

Clinical Study ID

NCT05935787
CTF-III-SR-2022
  • Ages 40-80
  • All Genders

Study 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

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 cerebralhemispheres, occurred in the previous 14-90 days before screening.

  4. Acute neuroimaging data (CT and/or MRI) do not contradict the clinical and topicaldiagnosis 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 ofthe 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 reproductivepotential.

  11. For men: consent to the use of adequate methods of contraception, or completeabstinence from sexual activity for the period of the study, or absent reproductivepotential.

Exclusion

Exclusion Criteria:

  1. Known hypersensitivity to any component of the study drug

  2. Severe visual and hearing impairments that prevent the implementation of studyprocedures.

  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 ofthe study protocol (including total aphasia).

  6. The presence of contraindications to complex rehabilitation in a hospital (lack ofrehabilitation potential, somatic diseases that prevent a complex of rehabilitationmeasures).

  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) ornootropic drugs in the previous 3 months before the patient was included in thestudy, except for stroke treatment in acute hospital.

  17. Alcohol or drug addiction

  18. Pregnancy, lactation.

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Phase: 3
Study Start date:
March 23, 2023
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • City General Hospital №2

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • City Hospital №40 of the Kurortny District

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

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