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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

41 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Vienna, 1080, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study 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.

Important dates

Study start: 2013
Primary completion: 2015
First posted: Jun 25, 2013
Registry last updated: Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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