NL-OMON43721已完成不适用
Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis - Methodology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Aged 18 to 80 years, inclusive, at the time of informed consent.
- •3. A diagnosis of sporadic or familial ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 [Brooks 2000]). Subjects meeting the definition of possible ALS must have both upper motor neuron (UMN) and lower motor neuron (LMN) signs/symptoms in at least 1 region.
- •4. ALS onset within *2 years.
- •5. Subjects not participating in the MRI substudy must have an upright SVC *50% of predicted value for age, height, and sex.
- •6. Subjects participating in the MRI substudy must have an upright SVC *65% of predicted value for age, height, and sex.
- •7. Women of childbearing potential must practice effective contraception for at least the first 12 months of the study. Further details of contraceptive requirements for this study are provided in Section 13.5.
排除标准
- •1. History of or positive test result at Screening for human immunodeficiency virus (HIV).
- •2. History of or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus ([HBV] defined as positive for hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb]).
- •3. Possibility of neuromuscular weakness other than ALS.
- •4. Presence of significant cognitive impairment, clinical dementia, or psychiatric illness, precluding informed consent.
- •5. Diagnosis of other neurodegenerative disease (e.g., Parkinson*s disease, Alzheimer*s disease, etc.)
- •6. History of unstable or severe cardiac, pulmonary, oncologic, hepatic, or renal disease, or other medically significant illness that would affect the specified assessments.
- •7. Active bacterial or viral infection at Screening or a serious infection (e.g., pneumonia, septicemia) within 30 days before Screening.
- •8. Enrollment in an interventional study at Screening. Subjects who enroll in a Biogen
- •interventional study subsequent to the Screening Visit may remain in this methodology
- •study; they do not need to be withdrawn.
- •9. History of substance or alcohol abuse (as determined by the site Investigator) within the last year that makes the subject unsuitable for enrollment.
- •10. Habitual use of any tobacco product, defined as >1 cigarette per day (or equivalent) within the last year, that makes the subject unsuitable for enrollment.
- •11. Pregnancy.
- •12. Inability to comply with study requirements.
- •13. Unspecified reasons that, in the opinion of the site Investigator, make the subject unsuitable for enrollment or unlikely to be able to complete, at a minimum, the Month 6 Visit.
- •In addition to criteria 1 through 13, a subset of subjects who consent to the lumbar puncture (LP) will not be allowed to undergo the LP procedure (but may still participate in the study, if all other eligibility criteria are met) if any of the following exclusion criteria exist at Screening:
- •14. Use of anticoagulants, with the exception of aspirin, or presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally, and could place a subject at an increased risk for intraoperative or postoperative bleeding. These can include, but are not limited to, anatomical factors at or near the LP site (e.g., vascular abnormalities, neoplasms, or other abnormalities) or abnormal platelet or coagulation test values at Screening (see study reference manual for a listing of normal ranges).
- •In addition to criteria 1 through 13, a subset of subjects who will participate in the spinal cord imaging substudy will be excluded from substudy entry (but may still participate in the study, if all other eligibility criteria are met) if any of the following exclusion criteria exist at Screening:
- •15. Presence of any condition that can interfere with subject safety, or with generating reliable MRI scans including, but not limited to, the inability to lie still for up to 90 minutes, claustrophobia, body weight exceeding 320.0 lbs. or girth exceeding the magnet bore, presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, or other metal objects).
- •16. Inability to complete all MRI scans (up to 12 months) due to dise
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