EUCTR2018-002721-29-GB进行中（未招募）1 期
Randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in patients with Mitochondrial Myopathy - AIMM: Acipimox in Mitochondrial Myopathy
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 120 人开始时间: 2019年6月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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:
- •i) Genetically proven diagnosis of m.3243A>G mutation or single large-scale mtDNA deletion, and
- •ii)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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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:
- •b)breast feeding
- •c)of childbearing potential with a positive urine pregnancy test
- •prior to starting trial IMP or;
- •d) 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
- •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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