Trial record 8 of 15 for:    affiris

Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008A)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT02216188
First received: August 12, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Biological: AFFITOPE® PD01A
Other: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Tolerability/Safety [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    • Occurrence of any AE
    • Occurrence of any SAE
    • Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)


Secondary Outcome Measures:
  • Immunological [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    - Titer of antibodies specific for the immunizing peptide, KLH (carrier protein), aSyn, bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods)


Other Outcome Measures:
  • Clinical Activity [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    • Change in motor symptoms (MDS-UPDRS III)
    • Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, PD NMS, cognition)
    • Change in biological and radiological markers (e.g. CSF alpha synuclein levels)


Estimated Enrollment: 32
Study Start Date: August 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: AFFITOPE® PD01A + Adjuvant
one injection of 15µg AFFITOPE® PD01A/ adjuvanted
Biological: AFFITOPE® PD01A
s.c. injection
Experimental: B: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/ adjuvanted
Biological: AFFITOPE® PD01A
s.c. injection
Control
Untreated control group
Other: Control
Untreated control group

  Eligibility

Ages Eligible for Study:   40 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02216188

Locations
Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Austria
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: Dieter Volc, Prim, Dr. Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
  More Information

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT02216188     History of Changes
Other Study ID Numbers: AFFiRiS 008A, 2014-002489-54
Study First Received: August 12, 2014
Last Updated: August 12, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 29, 2014