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Free Radical Scavenger
Edaravone (Radicava®/Radicava ORS®) for Amyotrophic Lateral Sclerosis
N/A
Waitlist Available
Led By James Berry, MD, MPH
Research Sponsored by Mitsubishi Tanabe Pharma America Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycles 1, 3, and 6 of each edaravone cycle (each cycle is 28 days).
Awards & highlights
Study Summary
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.
Eligible Conditions
- Amyotrophic Lateral Sclerosis
- Lou Gehrig's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycles 1, 3, and 6 of each edaravone cycle (each cycle is 28 days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycles 1, 3, and 6 of each edaravone cycle (each cycle is 28 days).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in levels of 3-nitrotyrosine (3-NT) as a potential biomarker of oxidative stress, inflammation or neurodegeneration.
Change in levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG) as a potential biomarker of oxidative stress, inflammation or neurodegeneration.
Change in levels of creatinine as a potential biomarkers of oxidative stress, inflammation or neurodegeneration.
+5 moreSecondary outcome measures
Change from baseline in hand-held dynamometry.
Change from baseline in slow vital capacity.
Change from baseline in the ALSAQ-40 (ALS Assessment Questionnaire).
+3 moreSide effects data
From 2006 Phase 4 trial • 401 Patients • NCT0020035630%
Constipation
12%
Insomnia
10%
Nasopharyngitis
6%
Back pain
6%
Headache
5%
Urinary tract infection
5%
Pruritus
5%
Diarrhea
3%
Cerebral infarction
1%
Vertigo
1%
Lymphoma
1%
Femur fracture
1%
Angina pectoris
1%
Pelvic fracture
1%
Ileus
1%
Anti-neutrophil cytoplasmic antibody positive vasculitis
1%
Depression
1%
Transient ischemic attack
1%
Anastomotic ulcer haemorrhage
1%
Asthma
1%
Cerebral haemorrhage
1%
Duodenal ulcer
1%
Arrhythmia
1%
Duodenal ulcer haemorrhage
1%
Femoral neck fracture
1%
Inguinal hernia
1%
Psychotic disorder due to a general medical condition
1%
Pneumonia
1%
Thrombotic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Edaravone
Ozagrel
Trial Design
1Treatment groups
Experimental Treatment
Group I: Edaravone (Radicava®/Radicava ORS®)Experimental Treatment1 Intervention
During an estimated 12-month period, eligible participants who are prescribed Edaravone within the approved indication will be invited to participate in the study.
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Who is running the clinical trial?
Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
2,852 Total Patients Enrolled
4 Trials studying Amyotrophic Lateral Sclerosis
344 Patients Enrolled for Amyotrophic Lateral Sclerosis
Massachusetts General HospitalOTHER
2,936 Previous Clinical Trials
13,198,421 Total Patients Enrolled
37 Trials studying Amyotrophic Lateral Sclerosis
10,920 Patients Enrolled for Amyotrophic Lateral Sclerosis
James Berry, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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