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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Affiris AG
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Tolerability and Safety
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 41 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Immunological and Clinical Efficacy(52 weeks)