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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT01568099
• Date of registration: 16/03/2012
• Prospective Registration: No
• Primary sponsor: Affiris AG
• Public title: Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
• Scientific 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
• Date of first enrolment: February 2012
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01568099
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Austria

Contacts

• Name: Dieter Volc, Prim. Dr.
• Affiliation: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent capability

- Early PD (= 4 years), Hoehn&Yahr Stages I/II and fulfill the UK Parkinson's Disease
Society Brain Bank Criteria

- Brain magnetic resonance imaging (MRI) scan and DAT-SPECT scan are consistent with
the diagnosis of PD

- Age between 45 and 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 PD was confirmed,
after approval by Sponsor

- Caregiver able to attend all visits with patient

- Stable doses of medications (levodopa (+/- benserazide, carbidopa), COMT inhibitors
(entacapone, tolcapone), non-ergot dopamine agonists (pramipexol, ropinirol,
rotigotine), the MAO-B inhibitor rasagiline and amantadine are allowed)

Exclusion Criteria:

- Women of childbearing potential without birth control or pregnant women

- Participation in another clinical trial

- Autoimmune disease or allergy to components of the vaccine

- Contraindications for MRI, DAT-SPECT, colonoscopy including biopsy or lumbar puncture

- Dementia

- History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical
neoplasia)

- Active infectious disease

- Immunodeficiency

- Significant systemic illness or psychiatric illness

- Parkinson-like disease secondary to drug therapy side effects

- Parkinson-plus syndromes

- Heredodegenerative disorders

- Alcoholism or substance abuse

- Prior treatment with experimental immunotherapeutics for PD including IVIG, with
immunosuppressive drugs or treatment with deep brain stimulation

- Venous status rendering it impossible to place an i.v. access



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Control

Biological: AFFITOPE® PD01A

Primary Outcome(s)

Tolerability/Safety [Time Frame: 12 month]

Secondary Outcome(s)

Clinical Activity [Time Frame: 12 month]

Immunological [Time Frame: 12 month]

Secondary ID(s)

2011-002650-31

AFF008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors