International Trial of Efficacy of Cytoflavin in Head Trauma

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 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.

Timeline

Start

2020-11-22

Primary completion

2024-05-07

Completion

2024-09-24

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.

Drugs

Indications