Completion of recruitment for a Phase I MS trial
Placebo-controlled Phase I study in n=20 progressive multiple sclerosis patients
Recently we finished recruiting for a Phase I trial in patients with progressive multiple sclerosis. This randomized, double-blind, placebo-controlled study was designed to assess the safety and tolerability of a new biologic as well as the pharmacodynamic and pharmacokinetic parameters of the substance after a single SC dose.
Thanks to our “direct-to-patient” marketing approach we managed to enrol twenty patients in total with enrolment rates of three to four patients per month. Our single-centre approach allowed us to complete the study very cost-effectively and in expedited timelines. During this study we employed state-of-the-art technologies like telemetry and cranial MRI to generate data as an added value for the sponsor. Indication-specific scoring (e.g. EDSS) was done in-house by our dedicated team of study physicians. Lymphocyte phenotyping was also done locally in cooperation with experts from the Charité Immunology Study Lab.