Clinical trial NCT05568615: Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
Official title: Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ALS
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.


Eligibility criteria: 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 who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).

Exclusion Criteria:

* Subjects of childbearing potential unwilling to use a highly effective method of contraception from the Visit #1 until 3 months after the last dose of study medication.
* 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 C-SSRS at Week 96 of the A03 study or at Week 48 of the A04 study.
* Subjects who are not eligible to continue in the study, as judged by the Investigator.

Primary outcomes:
measure: Number of Patients With AEs and Adverse Drug Reactions
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
measure: ALSFRS-R Total Score
timeFrame: up to 10 months or 31/Aug/2023
measure: Number of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day)
timeFrame: up to 10 months or 31/Aug/2023
Locations:
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Higashinagoya National Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
state: Chiba
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Koshi
country: Japan
facility: National Hospital Organization Kumamoto Saishun Medical Center
state: Kumamoto
city: Toyonaka-shi
country: Japan
facility: National Hospital Organization Osaka Toneyama Medical Center
state: Osaka
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Neurological Hospital
state: Tokyo
city: Shizuoka
country: Japan
facility: National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: