Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease (AFF011)
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|ClinicalTrials.gov Identifier: NCT02267434|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : October 31, 2016
Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinson's disease.
In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.
AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Neurodegenerative Diseases||Biological: Low dose AFFITOPE® PD03A + Adjuvant Biological: High dose AFFITOPE® PD03A + Adjuvant Biological: Adjuvant without active component||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's Disease|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Low dose AFFITOPE® PD03A + Adjuvant
4 injections of 15µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks
1 boost immunization 36 weeks after first injection
Biological: Low dose AFFITOPE® PD03A + Adjuvant
Experimental: High dose AFFITOPE® PD03A + Adjuvant
4 injections of 75µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks
1 boost immunization 36 weeks after first injection
Biological: High dose AFFITOPE® PD03A + Adjuvant
Placebo Comparator: Adjuvant without active component
4 injections of Placebo once every 4 weeks
1 administration 36 weeks after first injection
Biological: Adjuvant without active component
- Number of patients who withdraw due to Adverse Events (AEs) [ Time Frame: 12 months ]The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.
- Occurrence of Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]Evaluation of Adverse Events and Serious Adverse Events in regards to autoimmune reactions
- New findings or Change in pre-existing findings assessed in physical and neurological examinations over time (study period) [ Time Frame: 12 months ]
- Change in vital signs and Body mass over time (study period) [ Time Frame: 12 months ]The Evaluation of vital signs includes the changes in blood pressure, heart rate, respiratory rate and Body temperature over time (measured at each visit).
- Safety related Evaluation of MRI results of patients' brain after visit 5 and visit 8 compared to baseline [ Time Frame: 12 months ]MRI safety measures will e.g. include the occurrence of inflammatory reactions (meningoencephalitis), new/changed hemorrhages and lacunar infarcts.
- Clinical significance/changes in laboratory parameters over time (study period) [ Time Frame: 12 months ]Laboratory assessment includes hematology, biochemistry, coagulation, serology and urinanalysis.
- Immunological activity of AFFITOPE® vaccine PD03A [ Time Frame: 12 months ]Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
- Change in motor symptoms at visit 8 and visit 11 compared to baseline [ Time Frame: 12 months ]Change in motor symptoms: MDS Unified Parkinson's Disease Rating Scale (UPDRS) II and III
- Change in non-motor symptoms at visit 8 and visit 11 compared to baseline [ Time Frame: 12 months ]Change in non-motor symptoms: PDQ-39 (Parkinson's Disease Quality of Life-39)/PD non-motor symptom score, MDS UPDRS I (Movement Disorder Society Unified Parkinson's Disease Rating scale), cognitive test battery, HAM-D (Hamilton Depression Rating Scale)
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): NCT02267434
|Medical University Innsbruck, Department of Neurology|
|Innsbruck, Austria, 6020|
|Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität -Privatklinik Josefstadt|
|Vienna, Austria, 1080|
|Principal Investigator:||Werner Poewe, MD||Medical University Innsbruck, Department of Neurology, Innsbruck 6020, Austria|