Cytoflavin in the Complex Rehabilitation of Stroke Patients

NCT05935787 | Completed Phase 3 DMC

• 1 other identifier: CTF-III-SR-2022
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

  40 days

Study Arms (2)

Cytoflavin

EXPERIMENTAL

Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

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

Cytoflavin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (3)

City General Hospital №2

Saint Petersburg, Russia

Location

City Hospital №40 of the Kurortny District

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Stroke

Interventions

cytoflavin; Inosine; Niacinamide; Riboflavin; Succinic Acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Flavins; Pteridines; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Alexey Shmonin, Prof

  First St. Petersburg State Medical University named after I.P. Pavlov

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: June 30, 2023
• Primary Completion: June 26, 2024
• Study Completion: December 7, 2024
• Last Updated: April 14, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)