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

NCT02267434 | Completed Phase 1 DMC

• 2 other identifiers: AFFiRiS 0112014-000568-16
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Parkinson Disease; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (6)

• 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.

  12 months

• Occurrence of Adverse Events and Serious Adverse Events

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

  12 months

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

  12 months

• 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).

  12 months

• 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.

  12 months

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

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

  12 months

Secondary Outcomes (3)

• Immunological activity of AFFITOPE® vaccine PD03A

  12 months

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

  12 months

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

  12 months

Study Arms (3)

Low dose AFFITOPE® PD03A + Adjuvant

EXPERIMENTAL

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

High dose AFFITOPE® PD03A + Adjuvant

EXPERIMENTAL

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

Adjuvant without active component

PLACEBO COMPARATOR

4 injections of Placebo once every 4 weeks 1 administration 36 weeks after first injection

Biological: Adjuvant without active component

Interventions

Low dose AFFITOPE® PD03A + Adjuvant BIOLOGICAL

s.c. injection

Low dose AFFITOPE® PD03A + Adjuvant

High dose AFFITOPE® PD03A + Adjuvant BIOLOGICAL

s.c. injection

High dose AFFITOPE® PD03A + Adjuvant

Adjuvant without active component BIOLOGICAL

s.c. injection

Adjuvant without active component

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Affiris AG: lead
• PROSENEX AmbulatoriumbetriebsGMBH: collaborator
• Medical University Innsbruck: collaborator
• Forschungszentrum Juelich: collaborator

Study Sites (2)

Medical University Innsbruck, Department of Neurology

Innsbruck, 6020, Austria

Location

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität -Privatklinik Josefstadt

Vienna, 1080, Austria

Location

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Werner Poewe, MD

  Medical University Innsbruck, Department of Neurology, Innsbruck 6020, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: October 17, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

AU (2)