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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568099
• Other study ID #: AFF008
• Secondary ID: 2011-002650-31
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2012
• Last updated: August 14, 2015
• Start date: February 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Biological:
• AFFITOPE® PD01A
s.c. injection

Other:
• Control
Untreated control

Locations

Country	Name	City	State
Austria	Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability/Safety	Occurrence of any AE (including a clinical grading scale of AEs according to NCI-CTCAE Version 4.02 (2009) for assessments of AEs + toxicity and including a grading of local injection site reactions according to the FDA Guidance for Industry: Toxicity Scale for Healthy Adult and Adolescents Patients Enrolled in Preventive Vaccine Clinical Trials (2007)); Occurrence of any SAE; Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)	12 month	Yes
Secondary	Immunological	- Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein	12 month	No
Secondary	Clinical Activity	Change in motor symptoms (MDS-UPDRS III); Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, cognition); Change in biological and radiological markers (e.g. CSF alpha synuclein levels)	12 month	No