Mitsubishi Tanabe Pharma America Revises REFINE-ALS Biomarker Study Process to Enable Remote Participation
JERSEY CITY, N.J., Jan. 7, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation. (MTPA) today announced revisions to the REFINE-ALS biomarker study protocol to address the safety of people with amyotrophic lateral sclerosis (ALS) during the pandemic. The amendment gives patients the ability to consent to participate virtually, with the option to utilize telemedicine and home health agencies in lieu of hospital or in-office visits.
"In an effort to address the evolving concerns of the ALS community this year, we made it a priority to do what we can to support them during these unprecedented times," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "With that in mind, we are thankful to be able to offer a potential alternative for patients to be able to participate in the REFINE-ALS study in a virtual setting when in-person assessments are not possible, enabling us to continue fostering scientific knowledge."
The study, sponsored by MTPA and led by Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI), is designed to identify and measure specific biomarkers and clinical assessments in up to 300 people with ALS in the U.S. who have begun treatment on RADICAVA® (edaravone). There are approximately 40 sites across the country and the study will utilize the expertise of multiple specialty laboratories to assess biomarker samples for oxidative stress, inflammation, neuronal and muscle injury. Biomarkers will be measured prior to initiating treatment with RADICAVA, at the start of treatment, and at pre-specified time points throughout the 24-week study period (six cycles of treatment).
In addition, patients may opt in to receive their genetic results for five common mutations associated with the disease, including SOD1, TARDBP, C9ORF72, FUS and VCP. Advanced tele-genetic counseling will also be made available for those who choose to receive this information.
"There is much about ALS that we still don't know, but we're working toward learning more every day," said primary investigator James Berry, M.D., M.P.H., MGH NCRI, Boston. "We are grateful to MTPA for their support with these important changes to the REFINE-ALS study, and excited to be able to share with participants more about their genetic makeup in relation to ALS. I generally see research as a way forward to better understand this progressive disease, and for many patients, participating in a study that evaluates biomarkers is a way of giving back to the ALS community at large."
Patients interested in learning more about the trial can call (617) 724-2609 or visit ClinicalTrials.gov (NCT04259255) for more information.
About RADICAVA® (edaravone) IV
IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of RADICAVA?
The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com.
About Mitsubishi Tanabe Pharma America, Inc.
Overview of Mitsubishi Tanabe Pharma Corporation
1 RADICAVA® U.S. Prescribing Information. August 2018.
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SOURCE Mitsubishi Tanabe Pharma America, Inc.