Cytoflavin in the Complex Rehabilitation of Stroke Patients

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05935787

Collaborator

(none)

196

Enrollment

Locations

Arms

20.3

Anticipated Duration (Months)

65.3

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 23, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cytoflavin	Drug: 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
Placebo Comparator: Placebo	Drug: Placebo 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

Arm

Intervention/Treatment

Experimental: Cytoflavin

Drug: 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

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Change of performance [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
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
Pregnancy, lactation.

Contacts and Locations

Locations

	Site	City	Country
1	City General Hospital №2	Saint Petersburg	Russian Federation
2	City Hospital №40 of the Kurortny District	Saint Petersburg	Russian Federation
3	Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine	Saint Petersburg	Russian Federation