EUCTR2011-001131-23-IT进行中（未招募）不适用
A double-blind, placebo-controlled study in Huntington's Disease patients to determine the safety and tolerability of SEN0014196
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
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. Genetically confirmed, manifest HD (CAG [cytosine, adenine, and guanine] repeat length = 36) and motor signs of HD (including motor score of the UHDRS = 5). 2. Clinical Stages I to III (Total Functional Capacity Subscale Score [TFC] of = 3). 3. Patients must be anticipated to be ambulatory and able to attend outpatient visits for the duration of the study. 4. Patients must be aged = 30 years and = 70 years. 5. Body mass index between 18 and 31 kg/m2 inclusive, and a body weight greater than 50 kg. 6. Patients must be able to give informed consent or have a legal representative who can consent on their behalf. Patients must be able to comply with trial procedures. 7. Patients must have no clinically significant and relevant medical or psychiatric 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. 8. Male patients must agree to use condoms during the entire duration of the study and for 3 months following the last dose of study drug. 9. Females of childbearing potential (last menses less than 1 year prior to enrolment) · Must have a negative pregnancy test at Screening and at Baseline (Day 1). · Must not be breastfeeding. · Must either be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study and for 3 months after the last dose of the study drug. An effective method of birth control is defined as methods, either alone or in combination, which have a low failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, non-hormonal intrauterine devices, sexual abstinence, vasectomised partner or double-barrier contraception methods (eg, condom with diaphragm/occlusive cap and spermicide cream).
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1. Participation in a study or received an investigational drug within 30 days of the baseline visit. 2. Any prior or concomitant use of Class I or Class II histone deacetylase (HDAC) inhibitors such as Zolinza/vorinostat or belinostat. 3. Clinical evidence of significant or unstable medical illness in the Investigator’s judgement, including screening transaminases (AST or ALT) = 3 times the upper limit of normal (ULN), or an estimated glomerular filtration rate (GFR) (modification of diet in renal disease [MDRD] equation) of < 60 mL/min, or unexplained proteinuria or microscopic haematuria in an uncontaminated sample obtained at Screening and confirmed on repeat testing. 4. QTcF interval >450 ms in men and >470 ms in women or PR >220 ms, or other clinically relevant abnormal ECG findings that, in the Investigator’s judgement, would present an unacceptable risk to patient safety. 5. Women who are pregnant or breastfeeding. 6. Clinically significant abnormalities in the screening laboratory studies which, in the opinion of the Investigator, would interfere with participation in the study. 7. Current evidence or history (within 1 year of baseline) of psychosis, hallucinations or delusions, including major depression with psychotic features, as defined in the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR). Patients currently experiencing mild depression, or moderate depression which is adequately and appropriately treated in the judgement of the Investigator, can participate if depression is not expected to interfere with study participation. 8. Suicide risk, as determined by meeting any of the following criteria: - A suicide attempt within the past year or suicidal ideation within 60 days of the Baseline Visit (Day 1). - Significant risk of suicide, as judged by the Principal Investigator, based on the psychiatric interview or information collected in the C-SSRS. 9. Current diagnosis or history (within 1 year of baseline) of any alcohol or substance abuse (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. 10. Known allergy to any ingredient in the study drug (active and/or placebo). 11. A history of malignancy of any type within 2 years prior to screening. A history of surgically excised non-melanoma skin cancers is permitted. 12. Any relevant condition, behaviour, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for entry into the study.
研究者
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