12/20/2023 0 Comments Forward observation group![]() ![]() I would like to extend my sincere thanks to all the patients and investigators involved in the TRAVERS trial who helped us to reach this important milestone. AM-125 stimulates vestibular compensation, thereby helping patients to ‘get back on their feet' more quickly, which is what we have demonstrated in the TRAVERS trial. ![]() "For patients suffering from acute vertigo, regaining balance as quickly as possible is of utmost importance. "We are strongly encouraged by the key outcomes from the TRAVERS trial, which confirm the good safety and tolerability of AM-125, demonstrate its therapeutic activity and thus provide the first proof of concept in a model representative for various types of acute vestibular syndrome," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. So far, no drug treatment has been shown to be truly effective in accelerating and enhancing this vestibular compensation, which is why the results obtained with AM-125 in the TRAVERS trial appear to be very promising." "The brain reacts with central vestibular compensation to progressively mitigate this imbalance and physical rehabilitation exercises help to improve this process. ![]() "When the peripheral vestibular system suddenly loses its function, patients will experience acute vertigo and difficulties in maintaining balance even for walking a few steps," commented Paul van de Heyning, MD, Professor, Department of Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium, who served as the International Coordinating Physician of the TRAVERS trial. While the active group maintained this level during the subsequent observation period, the placebo group continued its spontaneous recovery course and ultimately converged with the former, resulting in a miss of the primary endpoint which had been set at 6 weeks.ĭescription: Macintosh HD:Users:DebraC:Desktop:Chart 2 - Full resolved Imbalance TRAVERS trial_00_00.jpg 7.5 seconds for placebo treated patients, which is a statistically significant improvement (p=0.0242 least square means in repeated-measure ANCOVA model, per protocol population). At the end of the treatment period, patients treated with AM-125 20 mg on average managed to maintain balance for 12.5 seconds vs. Further, administration of AM-125 resulted in a dose- and time-dependent improvement in balance and vestibular function. The TRAVERS trial demonstrated good safety and tolerability of AM-125 at doses up to 20 mg administered three times daily for four weeks. For reference, the trial also included 16 patients who received ‘open label' oral betahistine at 16 mg three times daily (the approved dose in most countries worldwide). Improvement in the "Tandem Romberg" test, which measures how long patients are able to maintain balance with their two feet aligned one after the other while they have their eyes closed, served as the primary efficacy outcome. In addition, all trial participants followed a standardized course of vestibular rehabilitation therapy. Patients were randomized to receive either AM-125 at up to 20 mg or a placebo three times daily for four weeks, which was followed by a two-week treatment-free observation period. The randomized, double-blind, placebo-controlled TRAVERS trial enrolled at more than ten study sites across Europe a total of 124 patients who suffered from acute vertigo following neurosurgery for the removal of a tumor. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced positive top-line data from its exploratory Phase 2 TRAVERS trial with AM-125 (intranasal betahistine) in acute vertigo and provided an update on its development plans. HAMILTON, BERMUDA / ACCESSWIRE / J/ Altamira Therapeutics Ltd. Treatment well-tolerated by study participants and safeĬompany plans a US FDA IND filing, and to partner AM-125Īltamira sees opportunity to provide novel treatment option with vestibular stimulant in therapeutic area neglected for decades Study provides proof-of-concept for enhancement and acceleration of vestibular recovery Significant improvement in balance after four-week treatment with AM-125 20 mg nasal spray vs.
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