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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

NCT04577404

CompletedPhase 3

Sponsor: Shionogi

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Interventions: MT-1186

Countries: United States, Canada, France, Germany, Italy, Japan

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Subjects must provide 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.
2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3. Subjects who successfully completed Study MT-1186-A01.

Exclusion Criteria:

1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
2. 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 Visit
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Locations (44)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Rogers, Arkansas, United States
  • Aurora, Colorado, United States
  • Gainesville, Florida, United States
  • Atlanta, Georgia, United States
  • Baltimore, Maryland, United States
  • Lincoln, Nebraska, United States
  • Winston-Salem, North Carolina, United States
  • Hershey, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Montreal, Quebec, Canada
  • Nice, Cedex 1, France
  • Limoges, Marcland, France
  • Bordeaux, France
  • Paris, France
  • Wiesbaden, Hesse, Germany
  • Hanover, Lower Saxony, Germany
  • Milan, Lombardy, Italy
  • Turin, Piedmont, Italy
  • Milan, Italy
  • Nagakute-shi, Aichi-ken, Japan
  • Chiba, Chiba, Japan
  • Fukuoka, Fukuoka, Japan
  • Fukushima, Fukushima, Japan
  • Sapporo, Hokkaido, Japan
  • + 14 more on CT.gov