NCT01568099

Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease

A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Affiris AG · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year. In addition, up to 8 patients will be offered participation within an untreated control group.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
BIOLOGICAL	AFFITOPE® PD01A	s.c. injection
OTHER	Control	Untreated control

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-04-02
• Last updated: 2015-08-17

Locations

1 site across 1 country: Austria