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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05935787
Other study ID # CTF-III-SR-2022
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 23, 2023
Est. completion date December 1, 2024

Study information

Verified date July 2023
Source POLYSAN Scientific & Technological Pharmaceutical Company
Contact Alexey Kovalenko, Doc Biol Sci
Phone +78127108225
Email science@polysan.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Russian Federation City General Hospital ?2 Saint Petersburg
Russian Federation City Hospital ?40 of the Kurortny District Saint Petersburg
Russian Federation Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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