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Trial record 4 of 6 for:    Affitope PD01A

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

Tracking Information
First Submitted Date  ICMJE March 16, 2012
First Posted Date  ICMJE April 2, 2012
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • Immunological [ Time Frame: 12 month ]
    - Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Biological: AFFITOPE® PD01A
    s.c. injection
  • Other: Control
    Untreated control
Study Arms  ICMJE
  • 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
Publications * McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01568099
Other Study ID Numbers  ICMJE AFF008
2011-002650-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiris AG
Study Sponsor  ICMJE Affiris AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
PRS Account Affiris AG
Verification Date August 2015

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