A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-002108-41-IT
- Lead Sponsor
- Mitsubishi Tanabe Development America Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 185
1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able to (in the judgement of the Investigator) 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, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
4. Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed.
5. Subjects will have a baseline forced vital capacity percentage (%FVC) = 70%.
6. Subjects whose first symptom of ALS has occurred within 3 years at the time of providing written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Exclusions Related to General Health or Concomitant Conditions:
1. Subjects undergoing treatment for a malignancy or those with a pending biopsy result.
2. Subjects who have the presence or history of any clinically significant 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.
3. Subjects of childbearing potential unwilling to use an acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active and who do not agree to use contraception during the study period.
4. Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
5. Subjects who have a significant risk of suicide. 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.
6. Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening.
7. Subjects with a glomerular filtration rate (GFR) <30 mL/min per 1.73 m2 at screening.
Exclusions Related to Medications:
8. Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
9. Subjects with hereditary fructose intolerance.
10. 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.
11. Subjects who are unable to take their medications orally.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method