ISRCTN26193242已完成1 期
A multicentre, multinational prospective observational imaging biomarker study in early stage Huntington?s disease (HD) patients to assess imaging techniques and parameters able to support efficacy studies with SEN0014196 in HD patients during Phase II and III studies
Siena Biotech (Italy)0 个研究点目标入组 60 人开始时间: 2011年6月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with early Huntington?s Disease (aged 18 to 70 years), i.e. genetically confirmed (CAG repeat length = 36) HD, motor signs of HD (motor score of the Unified Huntington's Disease Rating Scale [UHDRS] > 5) and a Total Functional Capacity (TFC) of = 7
- •2. All patients will have a body weight greater than 50kg
- •3. Female subjects must be surgically sterile or postmenopausal (defined as at least two years post cessation of menses and/or follicular stimulating hormone >18 mIU/mL and serum oestradiol <110 pmol/L), no spontaneous menstruation for at least one year before the first dose, nonlactating and have a negative serum pregnancy test
- •[Note: For postmenopausal females treated with estrogen replacement therapy, folloicle stimulating hormones (FSH) levels are artificially lowered < 40 IU/L. Estradiol and Luteinizing hormone (LH) measurements need to be performed to confirm reason for low FSH value. Hormone replacement therapy (HRT) is acceptable, provided the above criteria are respected].
- •4. All subjects must be capable of providing written informed consent
- •5. Subjects must have no clinically significant and relevant history that could affect the conduct of the study and evaluation of the data, as ascertained by the Investigator through detailed medical history and screening assessments
- •6. Male subjects participating in the trial and their female partners must agree to use a highly effective method of contraception from the time of taking the first dose of the study drug until three months after taking the last dose. This must include a condom or other barrier method (i.e. a diaphragm or cervical/vault cap), with spermicidal cream/gel plus one extra method (i.e. established use of oral, injected or implanted hormonal contraception or IUD or Coil). If the female partner is already pregnant, use of condoms is mandatory during sexual intercourse from the time of taking the first dose of study drug until three months after taking the last dose of study drug.
- •Target Gender: Male & Female; Upper Age Limit 70 years ; Lower Age Limit 18 years
排除标准
- •1. Participation in a study of an investigational drug within 30 days of the baseline visit
- •2. Subjects with presence of psychosis and/or confusional states
- •3. Subjects with clinically significant laboratory or electrocardiogram (ECG) abnormalities at screening
- •4. Subjects with clinically relevant haematological, hepatic, cardiac or renal disease
- •5. A medical history of infection with Human immunodeficiency virus, Hepatitis C and/or Hepatitis B
- •6. Any relevant condition, behaviour, laboratory value or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
- •7. Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat (Zolinza®) or have participated in a clinical trial using a histone deacetylase inhibitor
- •8. A history of malignancy of any type within 2 years prior to screening. A history of surgically excised nonmelanoma skin cancers is permitted
- •9. Subjects with a significant history of drug allergy as determined by the Investigator
- •10. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/ chemical abuse as determined by the Investigator (one unit of alcohol equals 285 mL of beer or lager, one glass [125 mL] of wine, or 25 mL of spirits)
研究者
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