Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA (AFF009)
|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: NCT02270489|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : June 5, 2017
This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA).
In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will 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 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.
AFF009 is part of the project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
|Condition or disease||Intervention/treatment||Phase|
|Multiple System Atrophy Neurodegenerative Diseases||Biological: AFFITOPE® PD01A + Adjuvant Biological: AFFITOPE® PD03A + Adjuvant Biological: Adjuvant without active component||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy|
|Actual Study Start Date :||December 11, 2014|
|Actual Primary Completion Date :||April 18, 2017|
|Actual Study Completion Date :||April 18, 2017|
Experimental: AFFITOPE® PD01A + Adjuvant
4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
1 boost immunization 36 weeks after first injection
Biological: AFFITOPE® PD01A + Adjuvant
Experimental: AFFITOPE® PD03A + Adjuvant
4 injections of 75µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks
1 boost immunization 36 weeks after first injection
Biological: 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 ]
- 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
- Physical Examination [ Time Frame: 12 months ]New findings or change in pre-existing findings assessed in physical examinations over time (study period)
- Vital signs [ Time Frame: 12 months ]Change in vital signs. The Evaluation 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 ]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
- Body mass [ Time Frame: 12 months ]Change of Body mass over time (study period)
- Neurological Examination [ Time Frame: 12 months ]New findings or change in pre-existing findings assessed in neurological examinations over time (study period)
- Immunological activity of AFFITOPE® vaccines PD01A and PD03A. [ Time Frame: 12 months ]Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
- Change in motor symptoms at Visit 5 and Visit 8 compared to baseline [ Time Frame: 12 months ]Change in Motor symptoms: UMSARS II (Unified Multiple System Atrophy Rating Scale), CGI (Clinical Global Impression Improvement scale)
- Change in non-motor symptoms at Visit 5 and Visit 8 compared to baseline [ Time Frame: 12 months ]Change in non-motor symptoms: UMSARS I and IV, GDS (Geriatric Depression Scale), COMPASS 31 (Composite Autonomic Symptom Score), MSA-QoL (MSA- Quality of life scale), MOCA (Montreal cognitive assessment), autonomic testing of cardiovascular function
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): NCT02270489
|University Hospital Bordeaux (Pellegrin Hospital)|
|Bordeaux Cedex, France, 33076|
|University Hospital Toulouse|
|Toulouse Cedex 9, France, 31059|
|Principal Investigator:||Wassilios Meissner, MD, PhD||University Hospital Bordeaux (Pellegrin Hospital), Bordeaux 33076, France|