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Quick Info
Status
Currently Recruiting
Phase
3
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
2 dose regimen
Enrollment
380
Start Date
11/13/2020
Contact Information
    Contact information unknown.
Locations
Canada, Alberta
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM), Edmonton, AB, T6G 2B7, Canada
Canada, New Brunswick
Regional Health Authority B, Fredericton, NB, E3B 0C7, Canada
Canada, Ontario
Health Science Center Mcmaster University, Hamilton, ON, L8P 1H1, Canada
Canada, Quebec
Recherche Sepmus, Inc, Greenfield Park, QC, J4V 2J2, Canada
Japan, Other
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders, Aoi-ku, Shizuoka-shi, 420-8688, Japan
Niigata University Medical & Dental Hospital, Asahimachidori, Chuo-ku, Niigata-shi, 951-8520, Japan
National Hospital Organization Chibahigashi National Hospital, Chuo-ku, Chiba-shi, 260-8712, Japan
Saitama Neuropsychiatric Institute, Chuo-ku, Saitama-shi, 338-8577, Japan
Tokyo Metropolitan Neurological Hospital, Fuchu-city, 183-0042, Japan
Kansai Electric Power Hospital, Fukushima-ku, Osaka-shi, 553-0003, Japan
Fukushima Medical University Hospital, Fukushima-shi, 960-1295, Japan
Teikyo University Hospital, Itabashi-ku, 173-8606, Japan
Yokohama City University Hospital, Kanazawa-ku, Yokohama-shi, 236-0004, Japan
National Hospital Organization Iou National Hospital, Kanazawa-shi, 920-0192, Japan
National Hospital Organization Kumamoto Saishun Medical Center, Koshi-shi, 861-1196, Japan
National Hospital Organization Higashinagoya National Hospital, Meito-ku, Nagoya-shi, 465-8620, Japan
Kagawa University Hospital, Miki-cho, Kita-gun, 761-0793, Japan
Hiroshima University Hospital, Minami-ku, Hiroshima-shi, 734-8551, Japan
Kitasato University Hospital, Minami-ku, Sagamihara-city, 252-0375, Japan
Murakami Karindoh Hospital, Nishi-ku, Fukuoka-shi, 819-8585, Japan
Toho University Omori Medical Center, Ota-ku, 143-8541, Japan
Shiga University of Medical Science Hospital, Otsu City, 520-2192, Japan
National Hospital Organization Hokkaido Medical Center, Sapporo-shi, 063-0005, Japan
Keio University Hospital, Shinjuku-ku, 160-8582, Japan
Nagoya University Hospital, Showa-ku, Nagoya, 466-8560, Japan
National Hospital Organization Utano National Hospital, Ukyo-ku, Kyoto City, 616-8255, Japan
Other, Other
Hanyang University Medical Center, Seoul, 04763, Other
United States, Arkansas
Woodland Research Northwest, Rogers, AR, 72758, United States
United States, Georgia
Emory University - School of Medicine, Atlanta, GA, 30322, United States
United States, Illinois
Northwestern University Feinberg School of Medicine, Chicago, IL, 60611-2605, United States
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21205, United States
United States, Nebraska
Neurology Associates, P.C. - Lincoln, Lincoln, NE, 68506-2960, United States
United States, Nevada
Las Vegas Clinic, Las Vegas, NV, 89145, United States
United States, New York
Dent Neurologic Institute, Amherst, NY, 14226, United States
United States, Pennsylvania
University Of Pittsburgh Medical Center, Pittsburgh, PA, 15261, United States
United States, Tennessee
Wesley Neurology Clinic, P.C., Cordova, TN, 38018, United States
United States, Texas
Nerve And Muscle Center Of Texas, Houston, TX, 77019, United States
United States, Virginia
Sentara Neurology Specialists, Virginia Beach, VA, 23456, United States
United States, West Virginia
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic, Morgantown, WV, 26506-9180, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>70
Months Since Onset
Number of months since first symptoms of ALS.
<2 years
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Open Label
Unknown
Update Notes
New sites added
6/14/2021
New sites added
6/7/2021
New sites added
5/25/2021
Site updates
5/18/2021
New site added
5/3/2021
New sites added
4/28/2021
New sites added
4/12/2021
New sites added
3/30/2021
New site added
3/18/2021
New sites added
3/5/2021
New sites added
3/3/2021
New sites added
2/1/2021
New site added, start date updated
12/28/2020
Start date updated, locations added, study protocols updated
12/9/2020
New outcome measure added
10/5/2020

Other Information

Purpose
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:
Eligibility
Inclusion Criteria:
1. Subjects must provide a signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
2. Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed.
3. Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS.
4. Subjects with a baseline score ≥ 2 points on each individual item of the ALSFRS- R at screening and baseline visits.
5. Subjects have a screening and baseline %forced vital capacity (FVC) ≥ 70%.
6. Subjects with 1 to 4 points decline for 8 weeks in ALSFRS-R total score between screening and baseline visits.
7. Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent.
Exclusion Criteria:
Exclusions Related to Primary Diagnosis 1. Subjects with a history of spinal surgery after the onset of ALS, such as surgery for cervical spondylosis or a herniated disc, or plans for such surgery during the study period.
Exclusions Related to Other Neurological Disorders (including, but not limited to the following) 2. Subjects with the possibility that the current symptoms may be symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy, cannot be ruled out.
Exclusions Related to General Health or Concomitant Conditions 3. Subjects undergoing treatment for a malignancy.
4. Subjects with a complication that could have a significant effect on efficacy evaluations, such as Parkinson's disease or syndrome, schizophrenia, bipolar disorder, and dementia.
5. Subjects who have the presence or history of any clinically significant (CS) disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
6. Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
7. Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication.
Subjects who are sexually active who do not agree to use contraception during the study period.
8. Subjects who have a significant risk of suicidality. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
9. Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening.
10. Subjects with a Glomerular Filtration Rate (GFR) < 30 mL/Min Per 1.73 m2 at screening, using the Larsson Equation.
Exclusions Related to Medications 11. Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
12. Subjects with hereditary problems of fructose intolerance (eg, fructose, sucrose, invert sugar, and sorbitol).
13. Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer, before providing informed consent for the present study.
14. Subjects who have received any previous treatment with edaravone.
15. Subjects who have received stem cell therapy.
16. Subjects who are unable to take their medications orally at baseline (Visit 2).
Details
Collaborator(s)
  • Mitsubishi Tanabe Pharma Development America, Inc.
Trial Protocol as Published on Clinicaltrials.gov
NCT04569084 (First Published: 9/23/2020)