Trial Outcomes & Findings for Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome (NCT NCT05647304)

Recruitment period : 11 October 2022 - 02 May 2023 One site located in France

Race and Ethnicity were not collected from any participant.

Percentage of patients with at least one ADE

Percentage of patients with at least one ADE per severity (mild, moderate and severe)

Percentage of patients with at least one AE

Percentage of patients with at least one DD

Evolution of the Near Point of Convergence (NPC)

Evolution of the deviation assessed via the Cover test considering both eyes The unilateral cover test was used in this investigation, which consists into covering one eye, horizontally moving a target 5 cm in front of both eyes, and then uncovering the covered eye and observing its reaction. If it fixes the target, this is normal: there is an orthophoria. If it moves to fix the target (restitution movement), the test is positive: there is a heterophoria in near vision. Patients who had visual corrections were to keep them during the test. The test was then repeated on the other eye. The outcome of this test was a deviation value, considering both eyes, comprised between 0 (better outcome = normal fixation) and 3 (worst outcome = deviated eye without restitution movement).

Evolution of the deviations assessed via Maddox rod test (horizontal deviation, vertical deviation of at least one eye)

Evolution of statokinesigram area with closed eyes The statokinesigram is the projection onto a 2-dimensional space of the trajectory of the patient's center of pressure. Its area is measured in mm2. The larger the area is, the higher the patient's imbalance is. The statokinesigram area was measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.

Evolution of the difference between left and right distributions of patient's body weight Patient's body weight left distribution, respectively right distribution, refer to patient's body weight distribution on his/her left foot, respectively right foot. The left distribution and the right distribution are two percentages which sum makes 100%. When body weight is well distributed between left and right feet (coherent balance), the difference between left and right distributions is ≤ 5%. When body weight is not well distributed between left and right feet (uncoherent balance), the difference between left and right distributions is \> 5%. These distributions were measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.

Evolution of the Trail Making Test part A and B (TMT A\&B) time to perform the task

Evolution of the SCAT5 (Sport Concussion Assessment Tool - 5th edition) score The SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed healthcare professionals. With this tool, the patient rates the intensity of every symptom from 0 (none) to 6 (severe) using a form. This enables to calculate the total number of symptoms (subscore from 0 to 22) and the symptom severity score (subscore from 0 to 132).

Evolution of the concentration of: * Anti-inflammatory cytokines InterLeukin (IL)-1 receptor antagonist, IL-4, IL-6, IL-10, IL-11 and IL-13 * S100 calcium binding protein B (S100B) * Glial Fibrillary Acidic Protein (GFAP) * Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) Of note: IL-11 and IL-13 could eventually not be analyzed due to undetectable low concentrations