NCT02267434

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Affiris AG · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Parkinson Disease
• Neurodegenerative Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Low dose AFFITOPE® PD03A + Adjuvant	s.c. injection
BIOLOGICAL	High dose AFFITOPE® PD03A + Adjuvant	s.c. injection
BIOLOGICAL	Adjuvant without active component	s.c. injection

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-10-17
• Last updated: 2016-10-31

Locations

2 sites across 1 country: Austria