Parkinson's DiseaseNCT01885494
AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
An observational study of Parkinson's Disease, run by Affiris AG at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 41 to 66 years
- Conditions the study is for
- Parkinson's Disease
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only participants of AFF008 will be offered participation in AFF008E.
Who may be able to join
- Written informed consent signed and dated by the patient
- Participation in AFF008
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32
Vienna, 1080
About this study
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.
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.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and Safety
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
Measured: 52 weeks
Secondary outcomes (1)
Immunological and Clinical Efficacy
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)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieter Volc, Prim. Dr., Principal investigator, Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885494
- Sponsor's protocol ID
- AFF008E
- Other IDs
- 2013-001774-20
- Status last verified
- Aug 2015
- First submitted
- 21 Jun 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.
PubMed 30741694
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01885494
- Acronym / sponsor ID
- AFF008E
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 41 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only participants of AFF008 will be offered participation in AFF008E.
Key inclusion criteria (2 listed)
- Written informed consent signed and dated by the patient
- Participation in AFF008
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Immunological and Clinical Efficacy
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Derived from this study: PubMed 30741694McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.
Related trials for Parkinson's Disease
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Volc, Prim. Dr. principal investigator
Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Affiris AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and Safety (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.