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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
Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights

Study Summary

This trial will compare the efficacy of two dosing regimens of oral edaravone in subjects with ALS. The primary endpoint is the change in ALSFRS-R score from baseline up to Week 48.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your symptoms of ALS started less than 2 years ago from the date you signed the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline to Week 48 of treatment
Secondary outcome measures
Change from baseline in % slow vital capacity (SVC) at Week 48
Change from baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48
Other outcome measures
Time to death, tracheostomy or permanent assisted mechanical ventilation (≥ 23 hours/day)

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 and PlaceboExperimental Treatment2 Interventions
Group II: MT-1186Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
MT-1186
2021
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
2,768 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,098 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
1,952 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project have an age restriction of seventy-five years or younger?

"As specified by the eligibility requirements, the minimum age for trial participation is 18 years old and the maximum age is 75 years old."

Answered by AI

Does this experiment have numerous test locations in North America?

"This trial is currently being conducted out of 44 different hospitals, with the UF Health Cancer Center in Gainesville, Florida, CHU de Quebec-Hopital-Enfant-Jesus in Quebec City, Quebec, and West virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic in Morgantown, West Virginia being some of the more notable ones."

Answered by AI

What other medical research has been published on MT-1186?

"Currently, 9 clinical trials are underway to study MT-1186. Of these 9 research projects, 3 are in Phase 3. Although the primary locations for these trials are in Shanghai, there are a total of 169 research sites running these trials."

Answered by AI

When will MT-1186 be cleared for use in the United States?

"Our company, Power, rates the safety of MT-1186 as a 3. This is based on the fact that MT-1186 is in Phase 3 clinical trials. Thus, there is some evidence of efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are there current vacancies for this research project?

"That is correct. The clinical trial in question, which was first announced on November 13th 2020, is still recruiting patients. In total, they are looking for 380 patients to be spread out across 44 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
2020. "Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569084.
~87 spots leftby Apr 2025
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