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Cytoflavin in the Complex Rehabilitation of Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Placebo
Sponsored by
POLYSAN Scientific & Technological Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 19. Pregnancy, lactation.

Sites / Locations

  • City General Hospital №2Recruiting
  • City Hospital №40 of the Kurortny DistrictRecruiting
  • Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cytoflavin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2023
Last Updated
July 7, 2023
Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT05935787
Brief Title
Cytoflavin in the Complex Rehabilitation of Stroke Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cytoflavin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of performance
Description
Change at the performance subscale (range 0-10, higher=better) of Canadian Occupational Performance Measure (COPM) score after completion of therapy compared to baseline
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 19. Pregnancy, lactation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexey Kovalenko, Doc Biol Sci
Phone
+78127108225
Ext
212
Email
science@polysan.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Kharitonova, MD, PhD
Phone
+79217450431
Email
t_haritonova@polysan.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexey Shmonin, Prof
Organizational Affiliation
First St. Petersburg State Medical University named after I.P. Pavlov
Official's Role
Study Director
Facility Information:
Facility Name
City General Hospital №2
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin V Golikov
Facility Name
City Hospital №40 of the Kurortny District
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina S Agafyina
Facility Name
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Polyakova

12. IPD Sharing Statement

Plan to Share IPD
No

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Cytoflavin in the Complex Rehabilitation of Stroke Patients

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