Parkinson's Disease Clinical Trial
Official title:
A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA
This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase
I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of
AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment
period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment
groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg
aluminium oxide).
Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A
or placebo during the participation in the clinical trial. Patients will either receive 75
µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The
treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male
and female patients aged 40 to 80 years can participate in the trial.
AFF010 is part of the project MULTISYN funded by the European Commission
(FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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