US-based clinical-stage biopharmaceutical company Cerecor has completed patient enrolment in its Phase II clinical trial of CERC-301, Clin301-203, as an oral, rapidly acting adjunctive treatment of major depressive disorder (MDD).
The company plans to report top-line data from the trial in November this year.
A total of 115 subjects with MDD who experienced a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor, were enrolled in this randomised, double-blind, placebo-controlled trial initiated last September.
The trial included two intermittent dose administrations for seven days, followed by 14 days of observation.
The main objective of the trial was to assess the anti-depressant effect of CERC-301 in 12mg and 20mg dosages in comparison to the placebo that was evaluated by the six-item uni-dimensional subset of the Hamilton Depression Rating Scale.
In November 2013, Cerecor secured a fast track designation by the US Food and Drug Administration (FDA) for CERC-301 for the treatment of MDD.
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The company claims CERC-301 has the potential to offer medication that could reduce depressive symptoms in a short time period, provided they are able to demonstrate efficacy and continued safety in their Phase II trial.
The company also plans to move forward with its Phase III development.
CEO Hermann Meyer said: “We are very excited to partner with ETSI for this first real life event.
“Over the past few years we have organised testing events and created an Interoperability Interest Group to enlarge the scope of these activities and cooperate with third parties in the development of an ITS standardisation roadmap.”
The event will also test the eco system of ITS technology that include infrastructure and applications placed inside vehicles in real life conditions.
The test site will feature variable message signs, traffic lights, Internet of things (IoT) sensors and cameras, as well as connectivity with the highway control centre.