Clinical Trial Details

Overview

Research Study Summary

Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis

Purpose

This study will assess a set of potential outcome measures to determine their relative utility for incorporation into future ALS POC studies.

To Learn more

CW ID: 210930
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Biogen
Facility Type
N/A

Eligibility

Inclusion Criteria:

To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening, or at the timepoint specified in the individual eligibility criterion listed:

  • 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
  • Aged 18 to 80 years, inclusive, at the time of informed consent
  • 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
  • ALS onset within ≤2 years
  • Subjects not participating in the MRI substudy must have an upright SVC ≥50% of predicted value for age, height, and sex
  • Subjects participating in the MRI substudy must have an upright SVC ≥65% of predicted value for age, height, and sex
  • Women of childbearing potential must practice effective contraception for at least the first 12 months of the study

Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening, or at the timepoint specified in the individual criterion listed:

  • History of or positive test result at Screening for human immunodeficiency virus (HIV)
  • 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])
  • Possibility of neuromuscular weakness other than ALS
  • Presence of significant cognitive impairment, clinical dementia, or psychiatric illness, precluding informed consent
  • Diagnosis of other neurodegenerative disease (e.g., Parkinson’s disease, Alzheimer’s disease, etc.)
  • History of unstable or severe cardiac, pulmonary, oncologic, hepatic, or renal disease, or other medically significant illness that would affect the specified assessments
  • Active bacterial or viral infection at Screening or a serious infection (e.g., pneumonia, septicemia) within 30 days before Screening
  • A score that is ≤10 on the cognitive portion and a score that is ≤32 on the behavioral portion of the ALS-CBS
  • Current enrollment in an interventional study that makes the subject unsuitable for enrollment
  • History of substance or alcohol abuse (as determined by the site Investigator) within the last year that makes the subject unsuitable for enrollment
  • 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
  • Pregnancy
  • Inability to comply with study requirements
  • 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 14, 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:

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 14, 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:

CONFIDENTIAL
The information contained herein may not be used, disclosed, or published without the written consent of
Biogen MA Inc.
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  • 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)
  • Inability to complete all MRI scans (up to 12 months) due to disease burden and rate of progression, in the opinion of the site Investigator

More Info

Protocol Number: 999AS003

Contact

Brittany Harvey
University of South Florida- Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33613
Phone: 813-974-9413

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