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Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
AFFITOPE® PD01A
Control
Sponsored by
Affiris AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

A: AFFITOPE® PD01A + Adjuvant

B: AFFITOPE® PD01A + Adjuvant

Control

Arm Description

4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks

4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks

Untreated control group

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2012
Last Updated
August 14, 2015
Sponsor
Affiris AG
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1. Study Identification

Unique Protocol Identification Number
NCT01568099
Brief Title
Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiris AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: AFFITOPE® PD01A + Adjuvant
Arm Type
Experimental
Arm Description
4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
Arm Title
B: AFFITOPE® PD01A + Adjuvant
Arm Type
Experimental
Arm Description
4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
Arm Title
Control
Arm Type
Other
Arm Description
Untreated control group
Intervention Type
Biological
Intervention Name(s)
AFFITOPE® PD01A
Intervention Description
s.c. injection
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Untreated control
Primary Outcome Measure Information:
Title
Tolerability/Safety
Description
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)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Immunological
Description
- Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Time Frame
12 month
Title
Clinical Activity
Description
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)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Volc, Prim. Dr.
Organizational Affiliation
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
City
Vienna
ZIP/Postal Code
1080
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
30741694
Citation
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.
Results Reference
derived

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Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease

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