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

Purpose

This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with aluminium oxide as 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.

Condition	Intervention	Phase
Parkinson's Disease	Biological: AFFITOPE® PD01A Other: Control	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:

Tolerability/Safety [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
- 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)

Secondary Outcome Measures:

Immunological [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Clinical Activity [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- 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)

Estimated Enrollment:	32
Study Start Date:	February 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A: AFFITOPE® PD01A + Alum 4 injections of 15µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide, once every 4 weeks	Biological: AFFITOPE® PD01A s.c. injection
Experimental: B: AFFITOPE® PD01A + Alum 4 injections of 75µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide, once every 4 weeks	Biological: AFFITOPE® PD01A s.c. injection
Control Untreated control group	Other: Control Untreated control

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568099

Locations

Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Austria, 1080

Sponsors and Collaborators

Affiris AG

Investigators

Principal Investigator:

Dieter Volc, Prim. Dr.

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

More Information

No publications provided

Responsible Party:	Affiris AG
ClinicalTrials.gov Identifier:	NCT01568099 History of Changes
Other Study ID Numbers:	AFF008, 2011-002650-31
Study First Received:	March 16, 2012
Last Updated:	February 7, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013