Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

  • STATUS
    Recruiting
  • End date
    Mar 24, 2022
  • participants needed
    380
  • sponsor
    Mitsubishi Tanabe Pharma Development America, Inc.
Updated on 24 September 2021
primary lateral sclerosis
edaravone

Summary

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 ScaleRevised (ALSFRS-R) score from baseline up to Week 48:

Details
Condition Amyotrophic Lateral Sclerosis, Antilymphocyte Serum, Amyotrophic Lateral Sclerosis (ALS), lou gehrig's disease
Treatment Placebo, MT-1186
Clinical Study IdentifierNCT04569084
SponsorMitsubishi Tanabe Pharma Development America, Inc.
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Subjects will be male or female, 18 to 75 years of age at the time the ICF is signed
Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS
Subjects with a baseline score 2 points on each individual item of the ALSFRS- R at screening and baseline visits
Subjects have a screening and baseline %forced vital capacity (FVC) 70%
Subjects with 1 to 4 points decline for 8 weeks in ALSFRS-R total score between screening and baseline visits
Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent

Exclusion Criteria

Exclusions Related to Primary Diagnosis
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)
\. 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
\. Subjects undergoing treatment for a malignancy
\. 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
\. 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
\. Subjects who are female and pregnant (a positive pregnancy test) or
lactating at the screening visit (Visit 1)
\. 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
\. 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
\. Subjects who have alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) elevations greater than 2 times the upper limit of
normal (ULN) at screening
\. Subjects with a Glomerular Filtration Rate (GFR) < 30 mL/Min Per 1.73 m2
at screening, using the Larsson Equation
Exclusions Related to Medications
\. Subjects with history of hypersensitivity to edaravone, any of the
additives or inactive ingredients of edaravone, or sulfites
\. Subjects with hereditary problems of fructose intolerance (eg, fructose
sucrose, invert sugar, and sorbitol)
\. 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
\. Subjects who have received any previous treatment with edaravone
\. Subjects who have received stem cell therapy
\. Subjects who are unable to take their medications orally at baseline
(Visit 2)
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