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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Affiris AG

ClinicalTrials.gov Identifier:

NCT01885494

First received: June 21, 2013

Last updated: August 14, 2015

Last verified: August 2015

History of Changes

Purpose

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
Parkinson's Disease


Study Type:	Observational
Study Design:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:

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:

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.


Enrollment:	30
Study Start Date:	June 2013
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	41 Years to 66 Years (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885494

Locations


Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32
Vienna, Austria, 1080

Sponsors and Collaborators

Affiris AG

Investigators


Principal Investigator:	Dieter Volc, Prim. Dr.	Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

More Information


Responsible Party:	Affiris AG
ClinicalTrials.gov Identifier:	NCT01885494 History of Changes
Other Study ID Numbers:	AFF008E 2013-001774-20 ( EudraCT Number )
Study First Received:	June 21, 2013
Last Updated:	August 14, 2015

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 19, 2017

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