Status:
COMPLETED
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity
Lead Sponsor:
Affiris AG
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-68 years
Phase:
PHASE1
Brief Summary
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in AFF008 will ...
Eligibility Criteria
Inclusion
- Prior participation in AFF008 and AFF008E
- Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
- In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
- Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
- Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator
Exclusion
- Women of childbearing potential without birth control or pregnant women
- Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
- Autoimmune disease or allergy to components of the vaccine
- History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
- Active infectious disease
- Immunodeficiency
- Significant systemic illness or psychiatric illness
- Alcoholism or substance abuse
- Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
- Venous status rendering it impossible to place an i.v. access
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02216188
Start Date
August 1 2014
Last Update
August 17 2015
Active Locations (1)
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1
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Vienna, Austria