MedTrace Logo

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

NCT02267434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-10-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PROSENEX AmbulatoriumbetriebsGMBH

    collaborator UNKNOWN

  • Medical University Innsbruck

    collaborator OTHER

  • Forschungszentrum Juelich

    collaborator OTHER

  • Affiris AG

    lead INDUSTRY

Principal Investigators

  • Werner Poewe, MD · Medical University Innsbruck, Department of Neurology, Innsbruck 6020, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267434 on ClinicalTrials.gov