New combo therapy aims to boost brain repair after stroke
NCT ID NCT05935787
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a drug called Cytoflavin to standard physical rehab helps stroke survivors recover better. Cytoflavin is an antioxidant that may protect brain cells and improve learning of new skills. The trial involved 240 adults aged 40-80 who had a stroke 2 weeks to 3 months earlier. Half got Cytoflavin plus rehab, the other half got placebo plus rehab, and researchers measured changes in daily living skills.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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240 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City General Hospital №2
Saint Petersburg, Russia
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City Hospital №40 of the Kurortny District
Saint Petersburg, Russia
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Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Saint Petersburg, Russia
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