Parkinson's Disease Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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