A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis
NCT ID: NCT03945279
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2019-05-30
2021-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1: BIIB100 Dose 1
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 2: BIIB100 Dose 2
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 3: BIIB100 Dose 3
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 4: BIIB100 Dose 4
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 5: BIIB100 Dose 5
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 6: BIIB100 Dose 6
Participants will receive single oral dose of BIIB100 on Day 1.
BIIB100
Administered as specified in the treatment arm.
Cohort 1-6: Matching Placebo
Participants will receive single oral dose of matching placebo on Day 1.
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB100
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Participants taking concomitant riluzole at study entry must be on a stable dose for greater than or equals to (\>=) 30 days prior to the first dose of study treatment (Day 1). Participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study.
* Participants taking concomitant edaravone at study entry must be on a stable dose for \>= 60 days prior to the first dose of study treatment (Day 1).
* Adequate respiratory function as indicated by slow vital capacity (SVC) \>= 65% of predicted value as adjusted for sex, age, and height (from the sitting position).
Exclusion Criteria
* Significant cognitive impairment or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression less than or equals to (\<=) 90 days of Screening, which in the opinion of the Investigator would interfere with the study procedures.
* Treatment with drugs that are transported by Breast Cancer Resistance Protein (BCRP) and P-glycoprotein (P-gp) including, but not limited to, rosuvastatin, sulfasalazine, dabigatran, digoxin and fexofenadine.
* Current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, whichever is longer, prior to the Baseline Visit (pre-dose on Day 1). Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator and after consultation with the Sponsor.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Diego Medical Center
San Diego, California, United States
Mayo Clinic Hospital
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins University, Dept of Neurology
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Alliance for Multispecialty Research NOCCR/VRG
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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261AS101
Identifier Type: -
Identifier Source: org_study_id
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