EUCTR2009-011743-39-GB进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration Proof of Concept study in patients with Huntington's disease to assess the efficacy, safety and tolerability of AFQ056 in reducing chorea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
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. Male and female patients between 30 and 85 years of age (both inclusive).
- •2. Patients diagnosed with Huntington’s Disease based on DNA testing (polyQ =36).
- •3. Patients with a UHDRS maximal chorea score of >10.
- •4. Patients treated with neuroleptics, antidepressants, and/or benzodiazepines are allowed to enter the study provided that they are on a stable regimen for at least 4 weeks prior to randomization.
- •5. Female subjects must be without childbearing potential (post-menopausal or surgically sterilized).
- •Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening.
- •For post-menopausal females treated with estrogen replacement therapy, FSH level is artificially lowered <40 IU/L. Estradiol and LH measurements need to be performed to confirm reason for low FSH value.
- •Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
- •All female subjects must have negative pregnancy test results at screening and at each baseline.
- •6. Male patients must be using a double-barrier local contraception for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following the last study drug administration.
- •7. Subjects must have a BMI in the range of 18-32 to participate in the study.
- •8. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with marked cognitive impairment (MMSE score of less than 18).
- •2. Patients with a presence of psychosis, confusional states and/or repeated hallucinations.
- •3. Patients who participated in an anti-dyskinetic clinical study within 6 months prior to randomization, and/or in any clinical investigation within 4 weeks prior to randomisation, or longer if required by local regulations, and any other limit on participation based on local regulations.
- •4. Patients using (or have used within four weeks before randomization) concomitant medications that are strong inhibitors of CYP3A4. E.g., ketoconazole, ritonavir, etc.
- •5. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •6. Significant illness (other than Huntington’s Disease) within two (2) weeks prior to initial dosing.
- •7. A past medical history of clinically significant ECG abnormalities or a family history grandparents, parents and siblings) of a prolonged QT-interval syndrome.
- •8. Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- •9. History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- •10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical laboratory test results at screening and baseline.
- •11. Total WBC count which falls outside the normal ranges of the laboratory at screening, and deemed of clinical relevance by the investigator.
- •12. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •13. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •14. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.
- •15. Subjects who have been committed to an institution by way of an official or judicial order will be excluded from participation to the study.
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