ISRCTN14616801已完成2 期
AZAthioprine immunosuppression and disease modification in Parkinson’s Disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33234645/ protocol (added 04/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/08/2021:
- •1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •2. Aged between 50 and 80 years
- •3. Fluent English speaker, as assessed by the trial team during the screening assessment
- •4. Diagnosis of PD according to UK Parkinson’s Disease Society (UKPDS) Brain Bank Criteria, though a positive family history of PD will not be used to exclude participants
- •5. Disease duration <3 years
- •6. Adequate organ and marrow function, as defined below (measured within 42 days of first dose of trial medication):
- •6.1. Haemoglobin (Hb) =110 g/L
- •6.2. Platelet count =130 x 10(9)/L
- •6.3. Neutrophil count =1.5 x 10(9)/L
- •6.4. Renal function - creatinine clearance = 50mL/min
- •6.5. Hepatic function - Alanine aminotransferase (ALT) =2x the institutional upper limit of normal (ULN) and total bilirubin =2x ULN
- •Previous inclusion criteria:
- •1. Be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •2. Aged 50 years or over
- •3. Be a fluent English speaker
- •4. Have a diagnosis of PD according to UKPDS Brain Bank Criteria
- •5. Have a disease duration of < 3 years
- •6. Have a probability of poor outcome (postural instability/dementia/death) at 5 years from diagnosis > = 50%
- •7. Have adequate organ and marrow function, as defined below (measured within 42 days of first dose of trial medication):
- •7.1. Haemoglobin > = 110 g/L
- •7.2. Platelet count > = 130 x 10(9)/L
- •7.3. Neutrophil count > = 1.5 x 10(9)/L
- •7.4. Renal function- creatinine clearance > = 50mL/min
- •7.5. Hepatic function- alanine aminotransferase (ALT) < = 2 times the institutional upper limit of normal (ULN) and total bilirubin < = 2 times the
排除标准
- •Current exclusion criteria as of 18/08/2021:
- •1. Any use of immunomodulatory drugs such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide within the 12 months prior to screening
- •2. Any previous use of rituximab or alemtuzumab at any time
- •3. Treatment with oral corticosteroids for greater than 2 weeks within the 12 months prior to screening, or any oral steroid use in 3 months prior to screening
- •4. Regular use of NSAIDs including aspirin >75 mg, naproxen, ibuprofen, meloxicam on more than 2 days per week
- •5. Known inflammatory or autoimmune disease
- •6. Chronic or latent infection
- •7. Active infection requiring the use of parenteral antimicrobial agents within 2 months prior to the first dose of trial treatment
- •8. Skin malignancy or solid organ malignancy within the last 5 years prior to screening assessment
- •9. Current or previous haematological malignancy
- •10. Positive test for human immunodeficiency virus (HIV) or hepatitis
- •11. The inability to take or swallow oral medication
- •12. Dementia according to Movement Disorder Society (MDS) dementia criteria
- •13. Thiopurine methyltransferase (TPMT) deficiency <10 pmol/h/mg Hb
- •14. Lack of immunity to varicella zoster virus (VZV)
- •15. Negative Epstein-Barr virus (EBV) IgG
- •16. Chronic liver disease
- •17. Renal impairment - creatinine clearance <50 mL/min
- •18. Concomitant use of allopurinol (increases risk of myelotoxicity)
- •19. Any concurrent medical or psychiatric condition or disease (e.g. active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial
- •20. Receipt of live, attenuated vaccine within the last 30 days prior to the screening assessment. Note: enrolled patients should not receive live, attenuated vaccine while receiving azathioprine nor within 30 days of last dose of azathioprine
- •21. Women of childbearing potential. Female patients must be surgically sterile or be postmenopausal. Postmenopausal is defined as spontaneous cessation of regular menses for at least 12 consecutive months or follicle-stimulating hormone (FSH) blood levels in the testing laboratory’s respective postmenopausal range with no alternative pathological or physiological cause.
- •22. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after completion of trial drug
- •23. Known hypersensitivity to azathioprine or its excipients
- •24. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the screening assessment or is currently enrolled in an interventional investigational trial
- •25. High risk of severe COVID-19 on the basis of co-morbidity/frailty, on the judgement of the investigators (applicable during the COVID-19 pandemic).
- •Previous exclusion criteria:
- •1. Any use of immunomodulatory drugs such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide within the last 12 months
- •2. Any previous use of rituximab or alemtuzumab
- •3. Previous treatment with corticosteroids for greater than 2 weeks, or any steroid use in the last 3 months
- •4. Regular use of non-steroidal anti-inflammatory drugs including aspirin > 75 mg, naproxen, ibuprofen, meloxicam on more than 2 days per week.
- •5. Known inflammatory or autoimmune
研究者
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