Parkinson's DiseasePhase 1NCT01568099
Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
A Phase 1 study testing AFFITOPE® PD01A in people with Parkinson's Disease, run by Affiris AG at 1 site in Austria.
Trial summary
This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AFFITOPE® PD01A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2012to May 2014
- Phase
- Phase 1
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent capability
- Early PD (≤ 4 years), Hoehn\&Yahr Stages I/II and fulfill the UK Parkinson's Disease Society Brain Bank Criteria
- Brain magnetic resonance imaging (MRI) scan and DAT-SPECT scan are consistent with the diagnosis of PD
- Age between 45 and 65 years or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic PD was confirmed, after approval by Sponsor
- Caregiver able to attend all visits with patient
- Stable doses of medications (levodopa (+/- benserazide, carbidopa), COMT inhibitors (entacapone, tolcapone), non-ergot dopamine agonists (pramipexol, ropinirol, rotigotine), the MAO-B inhibitor rasagiline and amantadine are allowed)
Who cannot join
- Women of childbearing potential without birth control or pregnant women
- Participation in another clinical trial
- Autoimmune disease or allergy to components of the vaccine
- Contraindications for MRI, DAT-SPECT, colonoscopy including biopsy or lumbar puncture
- Dementia
- History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
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- Active infectious disease
- Immunodeficiency
- Significant systemic illness or psychiatric illness
- Parkinson-like disease secondary to drug therapy side effects
- Parkinson-plus syndromes
- Heredodegenerative disorders
- Alcoholism or substance abuse
- Prior treatment with experimental immunotherapeutics for PD including IVIG, with immunosuppressive drugs or treatment with deep brain stimulation
- Venous status rendering it impossible to place an i.v. access
Trial locations and contacts
1 site in 1 country.
Austria1 site
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, 1080
About this study
Official title: A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's Disease
This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year.
In addition, up to 8 patients will be offered participation within an untreated control group.
- Conditions
- Parkinson's Disease
- Being tested
- AFFITOPE® PD01A, Control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFFITOPE® PD01ABiological
s.c. injection
ControlOther
Untreated control
| Study group | Role | What they receive |
|---|---|---|
| A: AFFITOPE® PD01A + Adjuvant | Experimental | 4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks Receives: Biological: AFFITOPE® PD01A |
| B: AFFITOPE® PD01A + Adjuvant | Experimental | 4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks Receives: Biological: AFFITOPE® PD01A |
| Control | Other | Untreated control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability/Safety
- Occurrence of any AE (including a clinical grading scale of AEs according to NCI-CTCAE Version 4.02 (2009) for assessments of AEs + toxicity and including a grading of local injection site reactions according to the FDA Guidance for Industry: Toxicity Scale for Healthy Adult and Adolescents Patients Enrolled in Preventive Vaccine Clinical Trials (2007))
- Occurrence of any SAE
- Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)
Measured: 12 month
Secondary outcomes (2)
Immunological
- Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Measured: 12 month
Clinical Activity
- Change in motor symptoms (MDS-UPDRS III)
- Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, cognition)
- Change in biological and radiological markers (e.g. CSF alpha synuclein levels)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2014
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 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, Skodagasse 32, 1080 Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568099
- Sponsor's protocol ID
- AFF008
- Other IDs
- 2011-002650-31
- Status last verified
- Aug 2015
- First submitted
- 16 Mar 2012
- 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
- A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01568099
- Acronym / sponsor ID
- AFF008
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Apr 2012 (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.
This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year.
In addition, up to 8 patients will be offered participation within an untreated control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: AFFITOPE® PD01A + Adjuvant | Experimental | Biological: AFFITOPE® PD01A4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks |
| B: AFFITOPE® PD01A + Adjuvant | Experimental | Biological: AFFITOPE® PD01A4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks |
| Control | Other | Other: ControlUntreated control group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent capability
- Early PD (≤ 4 years), Hoehn\&Yahr Stages I/II and fulfill the UK Parkinson's Disease Society Brain Bank Criteria
- Brain magnetic resonance imaging (MRI) scan and DAT-SPECT scan are consistent with the diagnosis of PD
- Age between 45 and 65 years or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic PD was confirmed, after approval by Sponsor
- Caregiver able to attend all visits with patient
Key exclusion criteria (15 listed)
- Women of childbearing potential without birth control or pregnant women
- Participation in another clinical trial
- Autoimmune disease or allergy to components of the vaccine
- Contraindications for MRI, DAT-SPECT, colonoscopy including biopsy or lumbar puncture
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFFITOPE® PD01As.c. injection | Biological | A: AFFITOPE® PD01A + Adjuvant, B: AFFITOPE® PD01A + Adjuvant |
| ControlUntreated control | Other | Control |
Primary outcome
Tolerability/Safety
Time frame: 12 month
* Occurrence of any AE (including a clinical grading scale of AEs according to NCI-CTCAE Version 4.02 (2009) for assessments of AEs + toxicity and including a grading of local injection site reactions according to the FDA Guidance for Industry: Toxicity Scale for Healthy Adult and Adolescents Patients Enrolled in Preventive Vaccine Clinical Trials (2007)) * Occurrence of any SAE * Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)
2 secondary outcomes
Immunological
Time frame: 12 month
Clinical Activity
Time frame: 12 month
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.
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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, Skodagasse 32, 1080 Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFFITOPE® PD01A in people with 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 6 inclusion and 15 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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/Safety (time frame: 12 month). 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 NCT01568099, 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.