Using Cytoflavin to help stroke patients recover

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

This study is testing if a drug called Cytoflavin can help stroke patients recover better and learn new skills during their rehabilitation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (Industry-sponsored)
• Locations: 3 sites (Saint Petersburg and 2 other locations)
• Trial ID: NCT05935787 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Cytoflavin, a neurometabolic drug, on the rehabilitation of stroke patients. The study aims to determine if this combination of antioxidants can enhance neuroplasticity and improve motor learning in individuals recovering from ischemic or hemorrhagic strokes. Participants will receive either Cytoflavin or a placebo while undergoing outpatient rehabilitation, with assessments of their neurological deficits and rehabilitation potential. The hypothesis is that Cytoflavin will facilitate the acquisition of new cognitive and motor skills necessary for daily living.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40 to 80 who have experienced an ischemic or hemorrhagic stroke within the last 14-90 days and have measurable neurological deficits.

Not a fit: Patients with strokes occurring outside the specified time frame or those without measurable neurological deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance recovery outcomes for stroke patients, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using antioxidant therapies for stroke rehabilitation, suggesting potential success for this approach.

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.

Where this trial is running

Saint Petersburg and 2 other locations

• City General Hospital №2 — Saint Petersburg, Russian Federation (Recruiting)
• City Hospital №40 of the Kurortny District — Saint Petersburg, Russian Federation (Recruiting)
• Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine — Saint Petersburg, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Alexey Kovalenko, Doc Biol Sci

Conditions Stroke; stroke rehabilitation