Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
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
2 other identifiers
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedAugust 17, 2015
August 1, 2015
2.2 years
March 16, 2012
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Immunological
12 month
Clinical Activity
12 month
Study Arms (3)
A: AFFITOPE® PD01A + Adjuvant
EXPERIMENTAL4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
B: AFFITOPE® PD01A + Adjuvant
EXPERIMENTAL4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
Control
OTHERUntreated control group
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiris AGlead
Study Sites (1)
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, 1080, Austria
Related Publications (1)
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.
PMID: 30741694DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieter Volc, Prim. Dr.
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2012
First Posted
April 2, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
August 17, 2015
Record last verified: 2015-08