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Completed

NCT Number: NCT01568099

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Vienna, 1080, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFFITOPE® PD01A

Biological

s.c. injection

Control

Other

Untreated control

Primary outcomes

  1. Tolerability/Safety

    Time frame: 12 month

    • 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 outcomes

  1. Immunological

    Time frame: 12 month

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

  2. Clinical Activity

    Time frame: 12 month

    • 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)

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2012
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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