EUCTR2017-000748-16-NL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE
Minoryx Therapeutics S.L.0 个研究点目标入组 105 人开始时间: 2017年7月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- Male
入选标准
- •Main Study:
- •1. Provision of written informed consent to participate in the main study.
- •2. Male patients aged =18 to =65 years.
- •3. Diagnosis of ALD based on genetic testing.
- •4. Clinical evidence of spinal cord involvement, with an EDSS score between 2 and 6.
- •5. Ability to walk for 6 minutes, without or with rest, with usual walking aids (e.g. leg braces, cane or crutch).
- •6. Ability to stand on a force plate with closed eyes and with feet apart for a minimum of 20 seconds.
- •7. Either a normal brain MRI or a type-1 through type-5 pattern MRI abnormality in which the abnormality does not show presence of inflammation. Note: MRI is not required at V-1 if an MRI was obtained within the 6 months prior to the first day of screening.
- •8. Normal adrenal function or appropriate steroid replacement if adrenal insufficiency is present.
- •9. Patients who are surgically sterilized. If not surgically sterilized, patients should be willing to use adequate contraception and not donate sperm from the first dose of the study medication until 90 days after the follow-up visit. Adequate contraception for the male patient (and his female partner, if of childbearing potential) is defined as hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the patient, is also acceptable.
- •Extension Study:
- •1. Completion of the entire 96-weeks double-blind period of the study (Part 1).
- •2. Provision of written informed consent to participate in the extension study part.
- •3. Normal adrenal function or appropriate steroid replacement if adrenal function has changed during the double-blind treatment phase.
- •4. The following inclusion criteria of Part 1 will be modified:
- •age =18 to =65 years will no longer apply.
- •EDSS score between 2 and 6 will no longer apply.
- •Ability to walk for 6 minutes will no longer apply. If a patient is unable to walk for 6 minutes, the maximum time and walking distance will be recorded. If a patient is unable or refuses to walk at all, this will also be recorded.
- •Ability to stand on a force plate with eyes closed and feet apart for a minimum of 20 seconds will no longer apply. If a patient is no longer able to stand on a force plate for 20 seconds, this test will not be conducted.
- •Either a normal brain MRI or a type-1 through type-5 pattern MRI abnormality in which the abnormality does not show presence of inflammation (gadolinium enhancement) will no longer apply.
- •In case of brain MRI lesions making the patient eligible for HSCT, he is still eligible for the extension study, but treatment will be discontinued immediately before any transplant-related treatment is initiated.
- •A stable dose of Lorenzo´s Oil, botulinum toxin, N-acetylcysteine, baclofen, benzodiazepines, opiates and cannabis preparations, fampidrine and antioxidants will no longer apply.
- •All other inclusion criteria of Part 1 remain in place.
- •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 105
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main Study & Extension Study:
- •1. Any other chronic neurological disease with signs of spastic paraplegia
- •2. Known type 1 or type 2 diabetes.
- •3. Known intolerance to pioglitazone or any other thiazolidinedione.
- •4. Current treatment with immunosuppressant medication, except for corticosteroids.
- •5. Previous or current history of cancer, bone marrow transplantation, Congestive heart failure, significant liver and renal disorders, anemia, pulmonary or cardiac diseases, Cognitive or behavioral abnormalities, alcohol/drug abuse etc.
- •6. Reduced left-ventricular ejection fraction, or other clinically significant cardiac abnormalities on echocardiogram that in the investigator's opinion could predispose the subject to volume overload or its attendant consequences.
- •7. A positive result on laboratory tests for hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus antibody.
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