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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01568099
First received: March 16, 2012
Last updated: July 31, 2014
Last verified: July 2014

March 16, 2012
July 31, 2014
February 2012
May 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01568099 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Parkinson's Disease
  • Biological: AFFITOPE® PD01A
    s.c. injection
  • Other: Control
    Untreated control
  • Experimental: A: AFFITOPE® PD01A + Adjuvant
    4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
    Intervention: Biological: AFFITOPE® PD01A
  • Experimental: B: AFFITOPE® PD01A + Adjuvant
    4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
    Intervention: Biological: AFFITOPE® PD01A
  • Control
    Untreated control group
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01568099
AFF008, 2011-002650-31
Yes
Affiris AG
Affiris AG
Not Provided
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Affiris AG
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP