- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631484
International Trial of Efficacy of Cytoflavin in Head Trauma (MITRA)
International, Multicenter, Randomized, Single Blind, Placebo-controlled Study of Efficacy and Safety of CITOFLAVIN® in the Acute Period of Head Injury in Adults
The study will access the efficacy and safety of treatment with CITOFLAVIN® in patients with non-penetrating moderately severe traumatic brain injury (TBI). The study recruits patients 18-60 years with TBI, corresponding to the clinical diagnosis of brain contusion, with GCS score 9 -14 at the time of inclusion , with the estimated time of initiation of therapy within 24 hours from the estimated or established time of trauma, with post-traumatic amnesia, confusion or disorientation and absence of indications for neurosurgery or other surgical intervention under general anesthesia.
Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improvement of cognitive functions of the brain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Aleksey L Kovalenko, Doc Biol Sci
- Phone Number: 212 +78127108225
- Email: science@polysan.ru
Study Contact Backup
- Name: Tatiana Kharitonova, MD, PhD
- Email: t_haritonova@polysan.ru
Study Locations
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-
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Ivanovo, Russian Federation
- Recruiting
- Ivanovskaya Regional Clinical Hospital
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Contact:
- Tatiana A Bragina, MD, PhD
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Moscow, Russian Federation
- Recruiting
- City Clinical Hospital No. 67 named after L.A. Vorokhobov
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Contact:
- Vadim A Shandalin, MD, PhD
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Moscow, Russian Federation
- Recruiting
- Research Institute of Emergency Medicine n.a. N.V. Sklifosovsky
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Contact:
- Sergey S Petrikov, Prof
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Nizhny Novgorod, Russian Federation
- Recruiting
- Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
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Contact:
- Vera N Gridorieva, Prof
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Saint-Petersburg, Russian Federation, 197706
- Recruiting
- City Hospital of the Holy Martyr Elizabeth
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Stavropol', Russian Federation
- Recruiting
- Stavropol regional clinical hospital
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Contact:
- Vasiliy V Fisher, MD, PhD
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Yekaterinburg, Russian Federation
- Recruiting
- State Autonomous Healthcare Institution of the Sverdlovsk Region "Central City Clinical Hospital No. 23"
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Contact:
- Vadim V Gusev, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18-60 (inclusive).
- Clinical diagnosis of TBI, cerebral contusion of moderate severity without compression.
- The written consent of the legal representative or the decision of the council to include the patient in the study.
- Possibility of a full assessment of eye opening, speech and motor response by GCS.
- GCS at the time of inclusion 9 - 14 (inclusive).
- Time of initiation of study drug therapy within 24 hours after the estimated or determined time of injury.
- The presence of post-traumatic amnesia, confusion and disorientation.
- Absence of indications for neurosurgery or other surgical intervention under general anesthesia.
- Normal brain CT scan, or the presence of subarachnoid hemorrhage and / or contusion foci of I-III types according to Kornienko and / or limited or diffuse cerebral edema.
- The expected duration of hospital stay >= 10 days.
- Absence of a disabling neurological or mental illness, information about the patient's disability prior to injury.
- Possibility to perform all procedures stipulated by the study protocol
Exclusion Criteria:
- The need to use the therapy prohibited by the study protocol.
- Concomitant injury, except for cases of damage to the skeleton, soft tissues, internal organs, which do not require (1) surgical intervention under general anesthesia, and (2) are not an independent indication for hospital treatment.
- Past / planned surgical intervention for the current episode of trauma under general anesthesia.
- Penetrating open TBI.
Presence of the following lesions on the results of computed tomography (CT) of the brain performed prior to the patient's randomization:
- epidural hematoma or subdural hematoma;
- evidence of a previous head injury based on CT results;
- type IV contusion foci according to Kornienko's classification.
- Presence of any of the following risk factors for secondary brain injury at any time after TBI: hypoxia (SpO2 <90% based on pulse oximetry results); hypotension (systolic blood pressure <90 mm Hg) or shock;hypothermia (body temperature <35 ° C); clinical signs of respiratory failure, the need for mechanical ventilation.
- Drug addiction.
- Alcohol in saliva >=2 ‰ or a previous diagnosis of alcohol dependence.
- Depression of consciousness, presumably resulting from other reasons (for example, alcohol, drugs, drugs, poisonous substances).
- The presence of aphasia due to focal brain damage, which prevents communication with the researcher.
- Status epilepticus at the time of admission to the hospital or condition after an epileptic seizure.
- Pregnant and lactating women.
- Availability of information about concomitant chronic disease in the stage of decompensation.
- Intolerance to the components of CYTOFLAVIN®, anamnestic data on drug allergy to succinic acid, riboflavin, inosine, or nicotinamide.
- Severe renal or heart failure requiring restriction of the volume of injected fluid.
- The presence of a condition or disease that, in the opinion of the investigator, jeopardizes the patient's safety if the patient participates in the study, or may interfere with the performance of examination procedures, an objective assessment of the patient's condition, or distort the assessment of the outcome of TBI.
- Participation in any clinical study less than 3 months before the start of the study.
- Patients who are employees of the research center and their families.
- Language barrier.
- Availability of information that the patient is a stateless person or a citizen of another state
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Patients will receive treatment with the study drug, 20 ml twice a day IV, dissolved in 200 ml of 0.9% NS, for 10 days;patients will stay in the hospital for the the entire period of therapy.
Observation of patients and assessment of the main parameters of the efficacy and safety will continue for 14 days.
|
20 ml (2 ampoules, 10 ml each) dissolved in 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days.
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Placebo Comparator: Placebo
Patients will receive 20 ml placebo (0.9% sodium chloride solution) twice a day IV, dissolved in 200 ml of 0.9% NS, for 10 days; patients will stay in the hospital for the the entire period of therapy.
Observation of patients and assessment of the main parameters of the efficacy and safety will continue for 14 days.
|
20 ml of 0.9% sodium chloride (2 ampoules of 10 ml each), added to 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Galveston Orientation and Amnesia scale
Time Frame: 7 days
|
The proportion of patients with regression of post-traumatic amnesia by day 7 of treatment, defined as having a Galveston score of >75 points on 3 consecutive days, up to and including day 7 of treatment.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glasgow Coma Scale
Time Frame: 14 days
|
Daily assessment by GCS for the period up to 14 days of the study
|
14 days
|
Glasgow Outcome scale - Extended (GOS-E)
Time Frame: 90 days
|
Assessment by GOS-E after 3 months
|
90 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Trauma, Nervous System
- Wounds, Nonpenetrating
- Wounds and Injuries
- Craniocerebral Trauma
- Head Injuries, Closed
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Riboflavin
- Niacinamide
- Niacin
Other Study ID Numbers
- CTF-III-CCT-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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