Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients
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|ClinicalTrials.gov Identifier: NCT02758730|
Recruitment Status : Withdrawn
First Posted : May 2, 2016
Last Update Posted : August 5, 2016
This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg aluminium oxide).
Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A or placebo during the participation in the clinical trial. Patients will either receive 75 µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male and female patients aged 40 to 80 years can participate in the trial.
AFF010 is part of the project MULTISYN funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Biological: AFFITOPE® PD01A + Adjuvant Biological: Adjuvant without active component||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA|
|Estimated Primary Completion Date :||October 2017|
Experimental: AFFITOPE® PD01A + Adjuvant
3 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
Biological: AFFITOPE® PD01A + Adjuvant
Placebo Comparator: Adjuvant without active component
3 injections of Placebo once every 4 weeks
Biological: Adjuvant without active component
- Number of patients who withdraw due to Adverse Events (AEs) and reason for withdrawal [ Time Frame: 52 weeks ]
- Occurrence of any Serious Adverse Event (SAE) possibly, probably or definitely related to the study vaccine at any time during the study [ Time Frame: 52 weeks ]
- Occurrence of any Grade 3 or higher AEs possibly, probably or definitely related to the study vaccine within 4 weeks after the vaccinations [ Time Frame: 12 weeks (week 0 to 12) ]
- Occurrence of solicited local AEs [ Time Frame: up to 52 weeks ]Injection site pain, erythema (redness), hyperthermia at injection site, itching, edema (swelling), induration [hardening], granuloma within 1 week (Day 1-7) after the vaccinations: Severity and duration
- Occurrence of solicited systemic AEs [ Time Frame: up to 52 weeks ]Headache, myalgia (muscle pain), fever, fatigue, nausea within 1 week (Day 1-7) after the vaccinations: Severity and duration.
- Occurrence of unsolicited non-serious AEs within four weeks after the vaccinations [ Time Frame: 12 weeks (week 0 to 12) ]Severity, duration and relationship to vaccination
- Immunological activity of AFFITOPE® vaccine PD01A over time (study period) [ Time Frame: 52 weeks ]Titer of immunoglobulin G (IgG) Abs specific for the immunizing peptide (PD01A), the carrier (KLH) and the target (targeted native α-Synuclein (aSyn) epitope coupled to bovine serum albumin (BSA) (mandatory) or presented in different forms - particularly monomers, pre-fibrils and fibrils (optional)) assessed by Enzyme-Linked Immunosorbent Assay (ELlSA) (or an equivalent method)
- Imaging efficacy variables at visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]11C-Pittsburgh Compound B (11C-PIB), 18F-Fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET), resting-state functional magnetic resonance imaging (fMRI), diffusion-weighted/tensor magnetic resonance imaging (MRI), Magnetic Resonance-Spectroscopy
- Biomarker data at visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]β-Glucocerebrosidase (GCase) enzyme activity
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I, II, III and IV at visit 5 and visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]Change in motor/non-motor symptoms over time
- Parkinson's Disease Quality of Life-39 (PDQ-39) at visit 5 and visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]Change in non-motor PD symptoms over time
- Investigator's global evaluation scale at visit 5 and visit 6 (or EDV) [ Time Frame: 52 weeks ]Change in motor PD symptoms over time. The overall change in the severity of patient's illness, compared to patient's condition at the start of this clinical trial (Visit 1).
- Cognitive scales at visit 5 and visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]Change in non-motor PD symptoms over time (MOCA, Trail Making Test (TMF) A and B)
- Geriatric Depression Scale at visit 5 and visit 6 (or EDV) compared to baseline [ Time Frame: 52 weeks ]Change in non-motor PD symptoms over time
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): NCT02758730
|University Hospital Tübingen|
|Tübingen, Germany, 72076|
|Principal Investigator:||Thomas Gasser, Prof. Dr.||University Hospital Tübingen, 72076 Tübingen, Germany|