NCT02618941

Brief Summary

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved. In addition, up to 6 patients will be offered participation within an untreated control Group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

November 25, 2015

Last Update Submit

June 2, 2017

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

  • Occurrence of any Serious Adverse Events (SAE) that are related to the study drug

    12 months

  • 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 any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination

    12 months

Secondary Outcomes (1)

  • Immunological activity of AFFITOPE® vaccine PD01A

    12 months

Other Outcomes (4)

  • MDS-UPDRS Ia, II, III

    12 months

  • PDQ39

    12 months

  • PD NMS

    12 months

  • +1 more other outcomes

Study Arms (2)

AFFITOPE® PD01A + Adjuvant

EXPERIMENTAL

one injection of 75µg AFFITOPE® PD01A/adjuvanted

Biological: AFFITOPE® PD01A

Control

NO INTERVENTION

Untreated control group

Interventions

AFFITOPE® PD01ABIOLOGICAL

s.c. injection

AFFITOPE® PD01A + Adjuvant

Eligibility Criteria

Age40 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prior participation in AFF008, AFF008E and AFF008A
  • Written informed consent signed and dated by the patient and, preferentially, the caregiver
  • In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for These
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
  • All changes in conventional PD therapies must be available to the sponsor; in particular pharmacologic symptomatic PD medication allowing transformation to a Levodopa standard dose
  • A potential participant should 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 1 if considered relevant by the investigator

You may not qualify if:

  • Women of childbearing potential without birth control or pregnant women
  • Participation in another clinical trial within 3 months before Visit 1 (except AFF008A)
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Autoimmune disease or allergy to components of the vaccine
  • History of cancer (Exceptions: non-melanoma skin cancer, intraepithelial cervical neoplasia)
  • Active infectious disease (e.g., Hepatitis B, C)
  • Immunodeficiency
  • Significant systemic illness
  • Alcoholism or substance abuse
  • Prior and/or current treatment with experimental immunotherapeutics including IVIG with the exception of AFFITOPE® PD01A, with immune modulating drugs or treatment with deep brain stimulation
  • Venous status rendering it impossible to place an i.v. access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Vienna, 1080, Austria

Location

Related Publications (1)

  • 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.

    PMID: 30741694DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Dieter Volc, Prim. Dr.

    Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 2, 2015

Study Start

February 2, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

AU(1)