MN-166 for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
Atrium Health Neurosciences Institute, Charlotte, NCAmyotrophic Lateral SclerosisMN-166 - Drug
18 - 80
All Sexes
What conditions do you have?

Study Summary

This trial is testing a potential ALS treatment. It will last 18 months and compare the drug to a placebo.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points.

12 months
Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.
Changes from Baseline in Laboratory Values
Mean change from baseline of functional activity measured by ALSFRS-R at Month 12
Mean change from baseline on quality of life assessed by ALSAQ-5 at Month 12
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Responders, measured in percent of subjects overall, whose ALSFRS-R total score was stable or improved
Time to survival
Month 3
Mean change from baseline of muscle strength measured by hand-held dynamometry

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

MN-166 (Early ALS Cohort)
53%muscle weakness
26%Decreased appetite
21%muscle spasms
21%weight decreased
3%Lower limb fracture
3%intestinal obstruction
3%Deep vein thrombosis
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02238626) in the MN-166 (Early ALS Cohort) ARM group. Side effects include: muscle weakness with 53%, Fall with 41%, Fatigue with 35%, Decreased appetite with 26%, nausea with 21%.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

230 Total Participants · 2 Treatment Groups

Primary Treatment: MN-166 · Has Placebo Group · Phase 2 & 3

Experimental Group · 1 Intervention: MN-166 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, treatment phase week 6, months 3, 6, 9 and12 time points.

Who is running the clinical trial?

MediciNovaLead Sponsor
19 Previous Clinical Trials
1,320 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
105 Patients Enrolled for Amyotrophic Lateral Sclerosis
Kazuko Matsuda, MD PhD MPHStudy DirectorMedicinova Inc
3 Previous Clinical Trials
109 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your symptoms of weakness started less than 18 months ago.
You received a pneumococcal vaccine in the last 6 years.

Frequently Asked Questions

Are people of all ages welcome to participate in this clinical research?

"According to the specific eligibility requirements for this study, potential participants must fall between 18-80 years of age. There are 45 other clinical trials enrolling patients that are younger than 18 and 413 studies recruiting adults over 65." - Anonymous Online Contributor

Unverified Answer

Could I possibly join this experiment?

"This clinical trial is looking for 230 participants that currently have amyotrophic lateral sclerosis. The patients must be between 18-80 years old and meet the following additional requirements: Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory-supported];, ALS onset of ≤18 months from first clinical signs of weakness prior to screening;, If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiation of study drug;, If currently using ed" - Anonymous Online Contributor

Unverified Answer

Are we still able to enroll people in this experiment?

"According to the latest information available on, this trial is looking for participants. The study was originally posted on May 28th 2020 and updated September 14th 2020." - Anonymous Online Contributor

Unverified Answer

How many subjects are included in the data set for this research?

"In order to move forward with this research, we need 230 participants that fit the pre-determined inclusion criteria. These individuals can partake in the study at locations like the Montreal Neurological Institute and Hospital in Canada or Mayo Clinic / Rochester in Minnesota, USA." - Anonymous Online Contributor

Unverified Answer

Has this research been undertaken before?

"As of now, there are 6 ongoing trials for MN-166 in 27 cities and 3 countries. The first trial was completed in 2018 and it went through Phase 2 drug approval. A total of 2697 have been conducted since then." - Anonymous Online Contributor

Unverified Answer

Where are the different sites of this clinical study?

"This study is 26 patients strong and counting, with locations such as the Montreal Neurological Institute and Hospital in Montreal, Mayo Clinic / Rochester in Rochester, and Lehigh Valley Health Network in Allentown among others." - Anonymous Online Contributor

Unverified Answer

Is MN-166 a new medication or has it been trialed before?

"There are currently six ongoing clinical trials researching MN-166. Two of those studies have progressed to Phase 3. Although the majority of the research is based in Portland, Oregon, 33 different locations across the globe are running these tests." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.