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Head Trauma,ClosedPhase 3MITRANCT04631484

International Trial of Efficacy of Cytoflavin in Head Trauma

A Phase 3 study testing Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid) in people with Head Trauma,Closed, run by POLYSAN Scientific & Technological Pharmaceutical Company at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Head Trauma,Closed
What is being tested?
Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
8 sitesin 2 countries
Study dates
22 Nov 2020to 24 Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Russia7 sites

  • Ivanovskaya Regional Clinical Hospital

    Ivanovo

  • City Clinical Hospital No. 67 named after L.A. Vorokhobov

    Moscow

  • Research Institute of Emergency Medicine n.a. N.V. Sklifosovsky

    Moscow

  • Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko

    Nizhny Novgorod

  • City Hospital of the Holy Martyr Elizabeth

    Saint Petersburg, 197706

  • Stavropol Regional Clinical Hospital

    Stavropol

  • State Autonomous Healthcare Institution of the Sverdlovsk Region "Central City Clinical Hospital No. 23"

    Yekaterinburg

Other trials in Russia

Kazakhstan1 site

  • West Kazakhstan Medical University named after. M. Ospanov

    Aktobe, 030012

Other trials in Kazakhstan

About this study

Official title: 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.

Being tested
Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid), Placebo
Keywords
closed head injury, brain concussion, traumatic brain injury, TBI, Craniocerebral Trauma, posttraumatic amnesia
Medical subject headings
Head Injuries, Closed, Brain Concussion, Brain Injuries, Traumatic, Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • PlaceboDrug

    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

Study groups in NCT04631484
Study groupRoleWhat they receive
Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)ExperimentalPatients 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.
Receives: Drug: Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)
PlaceboPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Galveston Orientation and Amnesia scale

    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.

    Measured: 7 days

  2. Glasgow Outcome scale - Extended (GOS-E)

    Assessment by GOS-E after 3 months

    Measured: 90 days

Secondary outcomes (2)

  1. Glasgow Coma Scale

    Daily assessment by GCS for the period up to 14 days of the study

    Measured: 14 days

  2. Barthel Index

    Assessement of Barthel Activities of daily living Index on day 14 or discharge, whatever earlier

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start22 Nov 2020
  3. Primary completion7 May 2024
  4. Study completion24 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
International, multicenter, randomized, single blind, third party (outcome assessor) blinding
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631484
Sponsor's protocol ID
CTF-III-CCT-2019
Acronym
MITRA
Status last verified
Apr 2025
First submitted
12 Nov 2020
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kharitonova T, Bragina T, Ivanova E, Savello A, Skoromets T, Petrikov S. A multicenter, international, randomized, single-blind, placebo-controlled study of the efficacy and safety of inosine-nicotinamide-riboflavin-succinic acid in the acute period of traumatic brain injury in adults. Front Neurol. 2026 Jan 2;16:1683976. doi: 10.3389/fneur.2025.1683976. eCollection 2025.

    PubMed 41551305

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid) in people with Head Trauma,Closed, run by POLYSAN Scientific & Technological Pharmaceutical Company at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Galveston Orientation and Amnesia scale (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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