MONTPELLIER, FRANCE — Biotech firm Sensorion announced the initiation of patient enrollment in a Phase 2a study (SENS-111-202) to confirm the absence of certain side effects commonly experienced with meclizine (specifically, anticholinergic side effects like sedation and memory loss) during an evoked vestibular imbalance.
SENS-111-202 is a randomized, double-blind, double-dummy, placebo-controlled, cross-over trial in patients designed to assess the safety and pharmacodynamic effects of seliforant compared to meclizine and placebo in experimentally evoked vestibular imbalance.
Seliforant vs. Meclizine Trial
According to the announcement, the trial will be conducted in the Netherlands and subjects enrolled will each receive the 4 treatment regimens once, one week apart, in a random order. The 4 treatment regimens/conditions that will be studied include:
- Seliforant 100 mg
- Seliforant 200 mg
- Meclizine 50 mg
- Placebo condition
According to the company, the primary and secondary endpoints for the trial will include measures of vigilance and attentiveness, sedation, balance, and activity of seliforant based on the severity of induced nausea and associated symptoms.
“Globally, about 70,000 patients per year in Europe and USA suffer debilitating crises from AUV, and over 100 million suffer from some form of vertigo. Currently, there is no effective and safe immediate treatment for these events, which is critical for these patients. Seliforant has the potential to fill this significant medical need, and the aim of the SENS-111-202 trial is to validate seliforant’s safety and activity, and progress towards registration.”
–Nawal Ouzren, Sensorion CEO
Preclinical and clinical data have confirmed that seliforant modulates the peripheral vestibular apparatus, reduces symptoms associated with vestibular dysfunction, and is safe and well tolerated.
By comparing the effects of seliforant to meclizine, a drug with known anticholinergic side effects, and placebo, the SENS-111-202 study aims to confirm the absence of anticholinergic effects such as sedation and memory loss in patients receiving seliforant.