EUCTR2007-003331-23-IT进行中（未招募）不适用
A study investigating the safety and tolerability of deferiprone in patients with Friedreich's Ataxia - ND
APOPHARMA INC., TORONTO, ONTARIO0 个研究点目标入组 80 人开始时间: 2008年7月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Diagnosis of FRDA, with confirmed mutation (excludes point mutation) in the frataxin (FXN) gene and GAA repeats ≥ 400 on the shorter allele. Males or females aged 7 to 35 years. No exposure to idebenone, coenzyme Q10, vitamin C, vitamin E or other antioxidants as a supplement or as a drug therapy for a period of at least one month prior to start of treatment and during the study. Neurological testing: A FARS score >20 and <85 at Screening and Baseline. Female subjects of childbearing potential must have a negative pregnancy test at Baseline. If the subject is a heterosexual, sexually-active male, he confirms that he and/or his female partner will use an effective method of contraception for the length of the trial and for 30 days following completion of the study or early termination. Signed and witnessed written informed consent/assent, obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Iron deficiency defined as ferritin levels below the reference range for age- and sex-matched controls 2. Unable to complete T25FW AND with score > 5 minutes in the 9HPT. (Subjects who can complete T25FW or with a score ≤ 5 minutes in the 9HPT will be allowed to enrol if the score has not doubled compared to screening). 3. Abnormal ALT, greater than 2.0 times the upper limit of normal on two consecutive assessments. 4. Serum creatinine outside the normal reference range. 5. History or evidence of neutropenia defined by an absolute neutrophil count (ANC) < 1.5 x 109/L or thrombocytopenia defined by a platelet count <150 x 109/L. 6. Refusal to participate in screening procedures or unable to participate in screening procedures or unable to comply with the requirements of the protocol. 7. Receiving any investigational drug products or having received any investigational product within 30 days prior to enrolment into this study. 8. Subjects who have previously taken deferiprone. 9. Subjects who, in the opinion of the Investigator, represent poor medical, psychological or psychiatric risks, and for whom participation in an investigational trial would be unwise. 10. Pregnant, breastfeeding or planning to become pregnant during the study period. 11. History of malignancy. 12. History of alcohol or drug abuse. 13. Investigators, site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. 14. Hypersensitivity to the active substance (deferiprone) or any of the excipients in the oral solution. 15. QT interval > 450 ms at Baseline.
研究者
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