StrokePhase 3NCT05935787
Cytoflavin in the Complex Rehabilitation of Stroke Patients
A Phase 3 study testing Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) in people with Stroke, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesRussia
- Study dates
- 30 Jun 2023to 7 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Modified Rankin score 3-4.
- The possibility to visit outpatient rehabilitation at the research center.
- Ability to understand and comply with protocol requirements.
- For women: consent to use reliable methods of contraception or absent reproductive potential.
- 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.
Who cannot join
- Known hypersensitivity to any component of the study drug
- 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).
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- Aneurysmal subarachnoid hemorrhage.
- Previous (before the actual ictus) stroke with residual neurological deficit.
- Disability is primarily not attributed to the last stroke
- Severe renal failure
- Severe liver failure
- End stage of other chronic incurable diseases.
- Decompensated diabetes mellitus.
- History of cancer, mental illness, HIV infection, syphilis, tuberculosis, alcohol, drug or drug addiction.
- Established diagnosis of a mental or neurodegenerative disease
- 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.
- Alcohol or drug addiction
- 19. Pregnancy, lactation.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
City General Hospital №2
Saint Petersburg
City Hospital №40 of the Kurortny District
Saint Petersburg
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Saint Petersburg
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), Placebo
- Keywords
- stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)Drug
Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml/min, for 15 days + Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid), 2 tablets 2 times a day, for 25 days
PlaceboDrug
Placebo, 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml / min, for 15 days + Placebo, 2 tablets 2 times a day, for 25 days
| Study group | Role | What they receive |
|---|---|---|
| Cytoflavin | Experimental | Not described Receives: Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of performance
Change at the performance subscale (range 0-10, higher=better) of Canadian Occupational Performance Measure (COPM) score after completion of therapy compared to baseline
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Jun 2023
- Primary completion26 Jun 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Shmonin, Prof, Study director, First St. Petersburg State Medical University named after I.P. Pavlov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935787
- Sponsor's protocol ID
- CTF-III-SR-2022
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05935787
- Acronym / sponsor ID
- CTF-III-SR-2022
- Conditions
- Stroke
- Keywords
- stroke rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytoflavin | Experimental | Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- Known hypersensitivity to any component of the study drug
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml/min, for 15 days + Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid), 2 tablets 2 times a day, for 25 days | Drug | Cytoflavin |
| PlaceboPlacebo, 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml / min, for 15 days + Placebo, 2 tablets 2 times a day, for 25 days | Drug | Placebo |
Primary outcome
Change of performance
Time frame: 40 days
Change at the performance subscale (range 0-10, higher=better) of Canadian Occupational Performance Measure (COPM) score after completion of therapy compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Shmonin, Prof study director
First St. Petersburg State Medical University named after I.P. Pavlov
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) in people with Stroke, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of performance (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.