MT-1186 for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Amyotrophic Lateral Sclerosis
MT-1186 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 96 weeks

Up to 96 weeks
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 ALSFRS-R score from baseline in Study MT-1186-A02 to Weeks 12, 24, 36, and 48 in 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
Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 score from baseline in Study MT-1186-A02 to Weeks 24 and 48 in 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
The Combined Assessment of Function and Survival (CAFS) score from baseline in Study MT-1186-A02 to Weeks 24 and 48 in Study MT-1186-A04
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.
Time from the randomization date in Study MT-1186-A02 to death
Mechanical ventilation
Tracheostomy procedure

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

MT-1186
22%Fall
21%Muscular weakness
18%Constipation
10%Back pain
9%Dyspnoea
9%Insomnia
9%Dysphagia
8%Contusion
8%Fatigue
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%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%Oxygen saturation decreased
1%Weight decreased
1%Gastrostomy
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04165824) in the MT-1186 ARM group. Side effects include: Fall with 22%, Muscular weakness with 21%, Constipation with 18%, Back pain with 10%, Dyspnoea with 9%.

Trial Design

2 Treatment Groups

MT-1186 - Group 2
1 of 2
MT-1186 - Group 1
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: MT-1186 · Has Placebo Group · Phase 3

MT-1186 - Group 2Experimental Group · 2 Interventions: MT-1186, Placebo · Intervention Types: Drug, Drug
MT-1186 - Group 1
Drug
Experimental Group · 1 Intervention: MT-1186 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edaravone
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 96 weeks

Who is running the clinical trial?

Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,312 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
140 Patients Enrolled for Amyotrophic Lateral Sclerosis
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma Development America, Inc.
9 Previous Clinical Trials
1,196 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
140 Patients Enrolled for Amyotrophic Lateral Sclerosis

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study.
Subjects must be able to understand the nature of the study and all risks involved with participation in the study.
Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
Subjects must have completed all Study MT-1186-A02 visits and have been compliant with study drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Nerve And Muscle Center Of Texas100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Nerve And Muscle Center Of Texas: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call100.0%