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AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A

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ClinicalTrials.gov Identifier: NCT01885494
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Affiris AG

Study Description
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Brief Summary:
AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.

Condition or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.
Study Start Date : June 2013
Actual Primary Completion Date : February 2015

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Groups and Cohorts
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Group/Cohort
15µg AFFITOPE® PD01A
Patients With Parkinson's Disease vaccinated with 4 injections of 15µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
75µg AFFITOPE® PD01A
Patients With Parkinson's Disease vaccinated with 4 injections of 75µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
Control group
Untreated control group


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability and Safety [ Time Frame: 52 weeks ]

    These will be based on the following parameters:

    • Withdrawal criteria (continuation decision) Number of patients who withdraw due to adverse events Reason for withdrawal
    • Occurrence of any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study.
    • Occurrence of any adverse events possibly, probably or definitely related to the study vaccine


Secondary Outcome Measures :
  1. Immunological and Clinical Efficacy [ Time Frame: 52 weeks ]

    Immunological parameters:

    -Titer of antibodies specific for the immunizing peptide, keyhole limpet hemocyanin (carrier protein), α-Synuclein, β-Synuclein as assessed by Enzyme-Linked Immunosorbent Assay

    Clinical efficacy variables:

    Motor symptoms:

    • Movement Disorder Society Unified Parkinson's Disease Rating Scale III
    • Investigator's Global Evaluation scale Non-motor symptoms
    • Parkinson's Disease Quality of Life-39 / Parkinson's Disease Non Motor Symptoms
    • Movement Disorder Society Unified Parkinson's Disease Rating Scale II
    • Cognitive scales
    • Smell identification test
    • Movement Disorder Society Unified Parkinson's Disease Rating Scale Ia (Caregiver-based assessment)
    • Geriatric Depression Scale Biomarker data
    • Change in Dopamine Transporter - Single Photon Emission Computed Tomography signal (compared to AFF008 results)
    • Assessment of change of volume of relevant brain regions (compared to AFF008 results)


Biospecimen Retention:   Samples With DNA
Analyzing patients' DNA (isolated out of whole blood) for polymorphisms in genes/regions like REP1 or alpha-synuclein to correlate results with the progression rate of the disease.

Eligibility Criteria
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Ages Eligible for Study:   41 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only participants of AFF008 will be offered participation in AFF008E.
Criteria

Inclusion Criteria:

  • Written informed consent signed and dated by the patient
  • Participation in AFF008

Exclusion Criteria:

  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration
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): NCT01885494


Locations
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Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32
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
More Information
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Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01885494     History of Changes
Other Study ID Numbers: AFF008E
2013-001774-20 ( EudraCT Number )
First Posted: June 25, 2013    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
Neurodegenerative Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs