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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01568099
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Affiris AG

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: AFFITOPE® PD01A Other: Control Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A: AFFITOPE® PD01A + Adjuvant
4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
 Biological: AFFITOPE® PD01A
s.c. injection
Experimental: B: AFFITOPE® PD01A + Adjuvant
4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
 Biological: AFFITOPE® PD01A
s.c. injection
Control
Untreated control group
 Other: Control
Untreated control


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability/Safety [ Time Frame: 12 month ]
    • 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 :
  1. Immunological [ Time Frame: 12 month ]
    - Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein

  2. Clinical Activity [ Time Frame: 12 month ]
    • 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)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568099


Locations
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Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Austria, 1080
Sponsors and Collaborators
Affiris AG
Investigators
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Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01568099    
Other Study ID Numbers: AFF008
2011-002650-31 ( EudraCT Number )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases