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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Tolerability/Safety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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
研究组 & 干预措施
A: AFFITOPE® PD01A + Adjuvant
4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
干预措施: AFFITOPE® PD01A (Biological)
B: AFFITOPE® PD01A + Adjuvant
4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
干预措施: AFFITOPE® PD01A (Biological)
Control
Untreated control group
干预措施: Control (Other)
结局指标
主要结局
Tolerability/Safety
时间窗: 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)
次要结局
- Immunological(12 month)
- Clinical Activity(12 month)