Date: 2017-03-09
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: Sensorion (France)
Product: SENS-111
Action
mechanism: histamine-H4 receptor antagonist. SENS-111 is the first representative of the histamine type 4 receptor antagonist class tested in inner-ear pathologies. This drug candidate displays a neuromodulation effect of the neurosensorial inner ear cell function and is being developed for the symptomatic treatment of bouts of vertigo or tinnitus. SENS-111 is a small molecule that can be taken orally or via a standard injection, and is currently tested in human in phase 1b.
Disease: acute vertigo
Therapeutic
area:
Country:
Trial
details:
- The aim of this multi-center, randomized, double-blind, placebo-controlled study is to assess the safety and
efficacy of SENS-111 in 207 patients suffering from acute unilateral vestibulopathy. The primary endpoint
is the intensity of the vertigo expressed by the patient and measured using a visual analog scale. Sensorion
has already established collaborations with a number of specialized centers in the United States, Europe
and South Korea.
Latest
news:
- • On March 9, 2017, Sensorion announced that the HMA (Heads of Medicines Agencies, a European network of the Heads of the National Competent Authorities) has authorized it to conduct a Phase II trial of SENS-111 for treating acute severe vertigo, via the Voluntary Harmonization Procedure (VHP). The VHP enables Sensorion to conduct its Phase II clinical trial in all European Union countries.
- This new procedure considerably simplifies the trial’s organization because a single country’s authority coordinates requests and interactions with national drug agencies and centralized Sensorion’s responses and issued a joint opinion.
Importantly, the VHP, allows the trial to be conducted with a single clinical protocol for all European countries.
Patient enrollment is scheduled to begin during the first quarter of 2017.
- • On September 1st, 2016 ,Sensorion announced that it has obtained Investigational New Drug (IND) status from the FDA for SENS-111, enabling the company to initiate a clinical study in acute severe vertigo.
Is
general: Yes
