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Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease — AFF011  

Parkinson Disease Clinical Trial

Official title:
A Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's Disease

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02267434
Study type Interventional
Source Affiris AG
Contact
Status Completed
Phase Phase 1
Start date December 2014
Completion date August 2016
View Details
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