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Parkinson DiseasePhase 1AFF011NCT02267434

Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease

A Phase 1 study testing Low dose AFFITOPE® PD03A + Adjuvant, High dose AFFITOPE® PD03A + Adjuvant and Adjuvant without active component in people with Parkinson Disease and Neurodegenerative Diseases, run by Affiris AG at 2 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Parkinson Disease, Neurodegenerative Diseases
What is being tested?
Low dose AFFITOPE® PD03A + Adjuvant, High dose AFFITOPE® PD03A + Adjuvant and Adjuvant without active component
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
2 sitesAustria
Study dates
Dec 2014to Aug 2016
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 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with IPS diagnosed for less than 4 years and who present in Hoehn \& Yahr Stages I/II and fulfill the United Kingdom Parkinson's Disease Society Brain Bank Criteria
  • The result of a DAT-SPECT and MRI examination of the patient's brain has to be consistent with the diagnosis of PD
  • Written Informed Consent Form signed and dated by the patient
  • Age between 45 and 70
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
  • A potential participant treated with conventional PD therapies must be on stable doses for at least 3 months prior to Visit 0 and during the entire trial period and must be a stable responder
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  • Accepted PD medications include the following: levodopa (alone or in combination with benserazide, carbidopa), Catechol-O-methyltransferase inhibitors (entacapone, tolcapone), amantadine, non-ergot dopamine agonists (pramipexol, ropinirol, rotigotine), monoamine oxidase-B inhibitors (rasagiline, selegiline) and anticholinergic medication
  • A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) for at least 30 days prior to Visit 0, if considered relevant by the PI
  • Upon PI's opinion, no visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these

Who cannot join

  • Pregnant women
  • Sexually active women of childbearing potential who are not using a medically accepted birth control method throughout the study
  • Participation in another clinical trial within 3 months before Visit 0
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Presence or history of allergy to components of the vaccine, if considered relevant by the PI
  • Contraindication for MRI imaging such as metallic endoprosthesis or stent implantation in the last 6 months or allergy to MRI contrast agent
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  • Contraindication for DAT-SPECT
  • Contraindication for lumbar puncture such as anticoagulation
  • Dementia
  • History and/or presence of autoimmune disease, if considered relevant by the PI
  • Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
  • Active infectious disease (e.g., Hepatitis B, C)
  • Presence and/or history of Immunodeficiency (e.g., HIV)
  • Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies), if considered relevant by the PI
  • History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression
  • Parkinson-like disease secondary to drug therapy side effects (e.g., due to exposure to medications that deplete dopamine [reserpine, tetrabenazine] or block dopamine receptors [neuroleptics, antiemetics]
  • Parkinson-plus syndromes (e.g. MSA, PSP)
  • Heredodegenerative disorders
  • Alcoholism or substance abuse within the past year (alcohol or drug intoxication)
  • Prior and/or current treatment with experimental immunotherapeutics including intravenous immunoglobulin
  • Prior and/or current treatment with immunosuppressive drugs
  • Change in dose of standard treatments for PD within 3 months prior to Visit 0
  • Change in dose of previous and current medications which the patient is taking because of consisting illnesses according medical history (except PD therapies, these will be recorded separately) within the last 30 days prior to Visit 0, if clinically relevant
  • Treatment with deep brain stimulation
  • Venous status rendering it impossible to place an i.v. access
  • L-Dopa related motor complications (response fluctuations and/or dyskinesia)
  • Evidence for genetic forms of PD: leucine-rich repeat kinase 2 and Parkin

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

  • Medical University Innsbruck, Department of Neurology

    Innsbruck, 6020

  • Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität -Privatklinik Josefstadt

    Vienna, 1080

Other trials in Austria

About this study

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 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).

Being tested
Low dose AFFITOPE® PD03A + Adjuvant, High dose AFFITOPE® PD03A + Adjuvant, Adjuvant without active component
Medical subject headings
Parkinson Disease, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose AFFITOPE® PD03A + AdjuvantBiological

    s.c. injection

  • High dose AFFITOPE® PD03A + AdjuvantBiological

    s.c. injection

  • Adjuvant without active componentBiological

    s.c. injection

Study groups in NCT02267434
Study groupRoleWhat they receive
Low dose AFFITOPE® PD03A + AdjuvantExperimental4 injections of 15µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks 1 boost immunization 36 weeks after first injection
Receives: Biological: Low dose AFFITOPE® PD03A + Adjuvant
High dose AFFITOPE® PD03A + AdjuvantExperimental4 injections of 75µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks 1 boost immunization 36 weeks after first injection
Receives: Biological: High dose AFFITOPE® PD03A + Adjuvant
Adjuvant without active componentPlacebo comparator4 injections of Placebo once every 4 weeks 1 administration 36 weeks after first injection
Receives: Biological: Adjuvant without active component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who withdraw due to Adverse Events (AEs)

    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.

    Measured: 12 months

  2. Occurrence of Adverse Events and Serious Adverse Events

    Evaluation of Adverse Events and Serious Adverse Events in regards to autoimmune reactions

    Measured: 12 months

  3. New findings or Change in pre-existing findings assessed in physical and neurological examinations over time (study period)

    Measured: 12 months

  4. Change in vital signs and Body mass over time (study period)

    The Evaluation of vital signs includes the changes in blood pressure, heart rate, respiratory rate and Body temperature over time (measured at each visit).

    Measured: 12 months

  5. Safety related Evaluation of MRI results of patients' brain after visit 5 and visit 8 compared to baseline

    MRI safety measures will e.g. include the occurrence of inflammatory reactions (meningoencephalitis), new/changed hemorrhages and lacunar infarcts.

    Measured: 12 months

  6. Clinical significance/changes in laboratory parameters over time (study period)

    Laboratory assessment includes hematology, biochemistry, coagulation, serology and urinanalysis.

    Measured: 12 months

Secondary outcomes (3)

  1. Immunological activity of AFFITOPE® vaccine PD03A

    Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein

    Measured: 12 months

  2. Change in motor symptoms at visit 8 and visit 11 compared to baseline

    Change in motor symptoms: MDS Unified Parkinson's Disease Rating Scale (UPDRS) II and III

    Measured: 12 months

  3. Change in non-motor symptoms at visit 8 and visit 11 compared to baseline

    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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267434
Sponsor's protocol ID
AFFiRiS 011
Other IDs
2014-000568-16, 2014
Acronym
AFF011
Status last verified
Oct 2016
First submitted
4 Sep 2014
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose AFFITOPE® PD03A + Adjuvant, High dose AFFITOPE® PD03A + Adjuvant and Adjuvant without active component in people with Parkinson Disease and Neurodegenerative Diseases, run by Affiris AG at 2 sites 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 9 inclusion and 27 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Number of patients who withdraw due to Adverse Events (AEs) (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT02267434.

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 31 Oct 2016.

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