Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02267434
Brief Summary:
Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinson's disease.
In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants 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 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.
AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
Study:
NCT02267434
Study Brief:
Protocol Section:
NCT02267434