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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

Tracking Information
First Submitted Date June 21, 2013
First Posted Date June 25, 2013
Last Update Posted Date August 17, 2015
Study Start Date June 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2013)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Only participants of AFF008 will be offered participation in AFF008E.
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
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 Completed
Actual Enrollment
 (submitted: August 14, 2015)
30
Original Estimated Enrollment
 (submitted: June 21, 2013)
32
Study Completion Date Not Provided
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 41 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01885494
Other Study ID Numbers AFF008E
2013-001774-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Affiris AG
Study Sponsor Affiris AG
Collaborators Not Provided
Investigators
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
PRS Account Affiris AG
Verification Date August 2015