EUCTR2011-002744-27-GB进行中（未招募）不适用
Pharmacodynamic Studies of a Histone Deacetylase Inhibitor in FRDA - The effect of Nicotinamide (Vitamin B3) in Friedreich’s ataxia
Imperial College0 个研究点目标入组 0 人开始时间: 2011年9月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Patients must have a molecular genetic diagnosis of FRDA, consisting of a GAA-repeat expansion on both alleles of the FXN gene. 2. FRDA patients over the age of 18 years. 3. Patients must be well enough and willing to provide written informed consent. 4. A female subject is eligible to participate if she is of: • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <40 pg/ml (<140 pmol/L) is confirmatory]. • Child-bearing potential and agrees to use one of the following contraception methods: o Abstinence o Contraceptive Methods with a Failure Rate of < 1%: - Oral contraceptive, either combined or progestogen alone; - Injectable progestogen; - Implants of levonorgestrel; - Estrogenic vaginal ring; - Percutaneous contraceptive patches; - - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label; - Male partner(s) sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus vaginal spermicidal agent (foam/gel/film/cream/suppository).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients with significant clinical dysphagia, 2. Patients taking Sodium Valproate or any other known histone deacetylase inhibitor. 3. Patient’s participating in another clinical trial or who have done so within 30 days before screening. 4. Patients known to be positive for human immunodeficiency virus (HIV). 5. Patients with any additional medical condition or illness that, in the opinion of the Investigator would interfere with study compliance and/or impair the patient's ability to participate or complete the study. Concurrent diseases or conditions that may interfere with study participation or safety include liver disease, bleeding disorders, arrhythmias, organ transplant, organ failure, current neoplasm, poorly controlled diabetes mellitus, poorly controlled hypertension, clinically significant haematological or biochemical abnormality. 6. Patients with a history of substance abuse (e.g. alcohol or drug abuse) within the previous 6 months before enrolment. 7. Patients with a history of severe allergies. 8. Inability to provide informed consent. 9. Female patients who are lactating or pregnant (positive pre-randomisation serum pregnancy test) or plan to become pregnant during the study. 10. Unable or unwilling to provide written informed consent
研究者
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