5 results
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
The aim of this clinical phase IIa randomized, double-blind, placebo-controlled study is to investigate tolerability/ safety and clinical and immunological effects of the addition of a subcuteaneous injection of a VD3 analogue in the vicinity of the…
Secondary objectives:The secondary objectives include demonstration of clinical efficacy of SCIT with BM41 alone, with BM41 plus VD3 and with VD3 alone, all three compared to placebo. Efficacy will be analysed for the upper airways by titrated nasal…