AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
![]() |
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: NCT01885494 |
Recruitment Status :
Completed
First Posted : June 25, 2013
Last Update Posted : August 17, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Parkinson's Disease |
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 |

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
|
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Austria | |
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32 | |
Vienna, Austria, 1080 |
Principal Investigator: | Dieter Volc, Prim. Dr. | Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt |
Responsible Party: | Affiris AG |
ClinicalTrials.gov Identifier: | NCT01885494 |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |