NL-OMON43721
Completed
Not Applicable
Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis - Methodology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Sponsor
- Biogen
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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