Multiple System Atrophy Clinical Trial
Official title:
A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy
This is a randomized controlled parallel Group phase I study to investigate the safety and
immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE®
PD03A, given to patients with early Multiple System Atrophy (MSA).
In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment
arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A
(with adjuvant) and 6 patients in the control group who will receive the reference substance
(Placebo). Over a study duration of 52 weeks, the study participants will receive 4
injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks
after the first injection. Male and female patients aged 30 to 75 years can participate in
the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.
AFF009 is part of the project SYMPATH funded by the European Commission
(FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
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