Clinical trial NCT01568099: Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Tolerability/Safety
timeFrame: 12 month
Secondary outcomes:
measure: Immunological
timeFrame: 12 month
measure: Clinical Activity
timeFrame: 12 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Study officials:
affiliation: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
name: Dieter Volc, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.