2 results
Approved WMOPending
The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…
Approved WMOCompleted
The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).