Clinical Trial Alert: Phase 3b Study of Oral Edaravone in Adults with ALS
By Sujatha Gurunathan | Monday, October 11, 2021
Researchers at Mitsubishi Tanabe Pharma Development America, Inc. (MTPA) are seeking adults living with amyotrophic lateral sclerosis (ALS) to participate in a phase 3b clinical trial to evaluate the safety and efficacy of oral edaravone to treat ALS. Edaravone (brand name Radicava) was designed to help protect cells from damage caused by free radicals, and was approved by the US Food and Drug Administration (FDA) in 2017 as an intravenous infusion indicated to slow the progression of ALS. Oral edaravone is considered investigational because it has not yet been approved for use by the FDA.
This is a phase 3b, multicenter, randomized, double-blind study, which means that participants at different study sites will be randomly assigned to receive one of two dose amounts of oral edaravone or a placebo control. The total trial length for each participant will be approximately 58 weeks. Participants will be required to complete eight on-site visits and eight telephone visits, with an initial frequency of every four weeks and then later, every 12 weeks.
The drug will be administered orally. The effects of oral edaravone will be investigated using various measures, including vital signs, physical exam, weight measurement, questions about the patient’s well-being, including how ALS symptoms affect daily life and any suicidal thoughts, electrocardiogram (ECG), respiratory testing, laboratory testing, compliance with drug regimen, eDiary completion, and unsteadiness/sensory evaluation.
To be eligible, individuals must meet the following inclusion criteria:
- Provide informed consent
- Understand the nature of the study and all risks involved with participation
- Be willing to comply with all protocol restrictions and requirements
- Male or female, ≥ 18 to 75 years of age
- Diagnosis of Definite ALS or Probable ALS according to the El Escorial revised criteria
- Baseline %FVC ≥ 70% at screening
- Exhibit 1 to 4 points decline for 8 weeks in ALSFRS-R total score between screening and baseline visits
- First ALS symptom occurred within 2 years of providing written informed consent
Individuals may not be eligible to participate if they are affected by another illness or receiving another treatment that might interfere with the ability to undergo safe testing.
Please visit this link NCT04569084 for the full listing of inclusion and exclusion criteria.
Travel support is available for study participants and families.
To learn more about the study or inquire about participation, contact the Clinical Trials Information Desk, 800-313-9381 or MT1186@iconplc.com.
TAGS: Clinical Trial Alert, Clinical Trials, Drug Development, Research
TYPE: Blog Post
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