NCT02216188

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 AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved. In addition, up to 8 patients will be offered participation within an untreated control group.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

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

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 12, 2014

Last Update Submit

August 14, 2015

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Tolerability

    * Occurrence of any Adverse Events (AE) * Occurrence of any Serious Adverse Events (SAE) * Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)

    6 month

Secondary Outcomes (1)

  • Immunological

    6 month

Other Outcomes (1)

  • Clinical Activity

    6 month

Study Arms (3)

A: AFFITOPE® PD01A + Adjuvant

EXPERIMENTAL

one injection of 15µg AFFITOPE® PD01A/ adjuvanted

Biological: AFFITOPE® PD01A

B: AFFITOPE® PD01A + Adjuvant

EXPERIMENTAL

one injection of 75µg AFFITOPE® PD01A/ adjuvanted

Biological: AFFITOPE® PD01A

Control

OTHER

Untreated control group

Other: Control

Interventions

AFFITOPE® PD01ABIOLOGICAL

s.c. injection

A: AFFITOPE® PD01A + AdjuvantB: AFFITOPE® PD01A + Adjuvant
ControlOTHER

Untreated control group

Control

Eligibility Criteria

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

You may qualify if:

  • Prior participation in AFF008 and AFF008E
  • Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
  • 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
  • Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications 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 (except AFF008E) within 3 months before Visit 0
  • 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: basal cell carcinoma, intraepithelial cervical neoplasia)
  • Active infectious disease
  • Immunodeficiency
  • Significant systemic illness or psychiatric illness
  • Alcoholism or substance abuse
  • Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive 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, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

Vienna, Vienna, 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, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

    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

August 12, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

AU(1)