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Free Radical Scavenger

MT-1186 for Lou Gehrig's Disease

Phase 3
Waitlist Available
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 up to 96 weeks
Awards & highlights

Study Summary

This trial is comparing two dosing regimens of oral edaravone to see which is more effective in treating ALS. The primary outcome measure is time from randomization to either a 12-point decrease in ALSFRS-R score or death, whichever happens first.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happens first.
Secondary outcome measures
Change in ALSFRS-R score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04
Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04
The Combined Assessment of Function and Survival (CAFS) score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04
+3 more
Other outcome measures
Change in ALSFRS-R score from baseline in Study MT-1186-A02 to Weeks 12, 24, 36, and 48 in Study MT-1186-A04

Side effects data

From 2021 Phase 3 trial • 185 Patients • NCT04165824
22%
Fall
21%
Muscular weakness
18%
Constipation
10%
Back pain
9%
Dyspnoea
9%
Insomnia
9%
Dysphagia
8%
Fatigue
8%
Contusion
7%
Headache
7%
Muscle spasms
6%
Amyotrophic lateral sclerosis
6%
Salivary hypersecretion
5%
Musculoskeletal pain
5%
Rash
5%
Depression
3%
Respiratory failure
2%
Pneumonia
1%
Oxygen saturation decreased
1%
Cellulitis
1%
Upper Respiratory Tract Infection
1%
Covid-19
1%
Acute respiratory failure
1%
Pelvic pain
1%
Gait disturbance
1%
Dehydration
1%
Hyponatraemia
1%
Diabetic ketoacidosis
1%
Feeding disorder
1%
Completed suicide
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Muscle spasticity
1%
Chronic respiratory failure
1%
Pain
1%
Atrial fibrillation
1%
Patella fracture
1%
Restrictive pulmonary disease
1%
Lung disorder
1%
Lower limb fracture
1%
Weight decreased
1%
Gastrostomy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MT-1186

Trial Design

2Treatment groups
Experimental Treatment
Group I: MT-1186 - Group 2Experimental Treatment2 Interventions
Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.
Group II: MT-1186 - Group 1Experimental Treatment1 Intervention
Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-1186
2021
Completed Phase 3
~600
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
2,950 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,280 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,134 Total Patients Enrolled

Media Library

Edaravone (Free Radical Scavenger) Clinical Trial Eligibility Overview. Trial Name: NCT05151471 — Phase 3
Lou Gehrig's Disease Research Study Groups: MT-1186 - Group 1, MT-1186 - Group 2
Lou Gehrig's Disease Clinical Trial 2023: Edaravone Highlights & Side Effects. Trial Name: NCT05151471 — Phase 3
Edaravone (Free Radical Scavenger) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05151471 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the previous studies that have been done on MT-1186?

"Right now, there are 9 ongoing studies involving MT-1186 with 3 of them in Phase 3. Most research on MT-1186 is taking place in Shanghai but 188 total locations are running clinical trials for this medication."

Answered by AI

Is MT-1186 a health hazard for human beings?

"We believe that MT-1186 is relatively safe, as it has received a score of 3. This means that it is a Phase 3 trial, for which there is some data supporting efficacy and multiple rounds of safety data."

Answered by AI

Are we currently enrolling patients for this trial?

"From what is available on clinicaltrials.gov, it seems as though this study is still looking for patients to participate. The listing was put up on 1/11/2022 and the most recent update was on 11/11/2022."

Answered by AI

How many people are being included in this experiment?

"Based on the information available from clinicaltrials.gov, this clinical trial is still recruiting patients. The study was first posted on January 11th, 2022 and was last updated November 11th of the same year. They are looking for a total of 300 patients to be spread out over 16 locations."

Answered by AI

Is this a groundbreaking clinical trial?

"At present, there are 9 active studies for MT-1186 underway in 98 cities and 10 countries. The first study for MT-1186 was conducted in 2020 by Mitsubishi Tanabe Pharma Development America, Inc. This initial Phase 3 drug approval stage study involved 140 participants and completed successfully. Since 2020, a total of 18311 studies have been completed related to MT-1186."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Nerve And Muscle Center Of Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Nerve And Muscle Center Of Texas: < 48 hours
~64 spots leftby Mar 2025