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Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

NCT04259255 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-08-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

Edaravone (Radicava®/Radicava ORS®)

Participants will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles - 28 days per cycle, corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation. Biomarker testing and clinical assessments will be performed at baseline (at enrollment or before the start of cycle 1), and at cycles 1, 3, and 6. Dosing is 60 mg daily by intravenous infusion for 14 days for the initial treatment cycle, followed by daily dosing on 10 out of 14 days in subsequent treatment cycles.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Mitsubishi Tanabe Pharma America Inc.

    lead INDUSTRY

Principal Investigators

  • James Berry, MD, MPH · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259255 on ClinicalTrials.gov