ISRCTN12895613已完成未知
Randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in patients with Mitochondrial Myopathy
The Newcastle Hospitals NHS Foundation Trust0 个研究点目标入组 21 人开始时间: 2019年1月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36127727/ (added 27/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Must be able to provide full informed consent
- •2. Male or female patients = 16 years of age
- •3. Patients must fulfil the following:
- •3.1. Genetically proven diagnosis of m.3243A>G mutation or single large-scale mtDNA deletion, and
- •3.2. Evidence of myopathy as confirmed by the investigator
- •4. Able and willing, in the opinion of the investigator, to comply with all trial requirements
- •5. Willing for their GP and Specialist (if applicable), to be informed of their participation in the trial
- •6. Be on a stable dose of any current regular medication for at least four weeks prior to trial entry.
排除标准
- •1. Patients who are currently participating or have participated in a clinical trial of an investigational medicinal product within the 12-week period prior to the date of informed consent
- •2. Patients who have had an elective or emergency admission to hospital within the 4-week period prior to the date of informed consent
- •3. Patients with other known uncontrolled medical problems, which, in the opinion of the investigator, would preclude participation in the trial
- •4. Patients who are:
- •4.1. Pregnant
- •4.2. Breastfeeding
- •4.3. Of childbearing potential with a positive urine pregnancy test prior to starting trial IMP
- •4.4. Male or female of childbearing potential unwilling to use a double barrier method of contraception throughout the trial (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- •5. Patients with moderate to severe renal impairment (creatinine clearance < 60 ml/min)
- •6. Patients with a screening AST, ALT or Gamma GT result of more than 3 times the upper limit of normal
- •7. Patients with a platelet count of < 50 platelets/ ul of blood
- •8. Patients on treatment with methotrexate or other immunosuppressant medications
- •9. Patients with active known peptic ulcer or history of recurrent ulceration
- •10. Patients on treatment with warfarin, clopidogrel, regular high-dose (> = 300 mg OD) aspirin or other anticoagulant medications which in the opinion of the investigator precludes entry into the trial. Patients receiving high-dose aspirin who are able to come off aspirin for a period of 72 hours prior to any muscle biopsy sample will be eligible to participate
- •11. Patients with a medical history which in the opinion of the investigator contraindicates the use of low-dose aspirin
- •12. Patients who are already taking acipimox
- •13. Patients with an elective hospital admission scheduled during the trial period, which in the opinion of the investigator would preclude participation
研究者
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