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Phosphodiesterase inhibitor

MN-166 for ALS (COMBAT-ALS Trial)

Phase 2 & 3

Recruiting

Research Sponsored by MediciNova

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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]

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, treatment phase week 6, months 3, 6, 9 and12 time points.

Awards & highlights

COMBAT-ALS Trial Summary

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

Who is the study for?

This trial is for adults aged 18-80 with ALS diagnosed within the last 18 months. Participants must have a certain level of lung function and be able to swallow pills, without severe liver issues or psychiatric disorders that could interfere with assessments. They shouldn't be on high-dose Vitamin B12 injections or involved in other studies recently.Check my eligibility

What is being tested?

The study tests MN-166 against a placebo over 12 months to see if it's effective and safe for ALS patients, followed by everyone getting MN-166 for another six months. It's randomized (participants are put into groups by chance) and double-blind (neither participants nor researchers know who gets what treatment).See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, potential allergic reactions, or changes in liver enzymes which will be monitored throughout the trial.

COMBAT-ALS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ALS according to the El Escorial criteria.

COMBAT-ALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, treatment phase week 6, months 3, 6, 9 and12 time points.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, treatment phase week 6, months 3, 6, 9 and12 time points.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, treatment phase week 6, months 3, 6, 9 and12 time points. 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 from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.

Secondary outcome measures

Changes from Baseline in Laboratory Values

Mean change from baseline of functional activity measured by ALSFRS-R at Month 12

Mean change from baseline of muscle strength measured by hand-held dynamometry

+4 more

Side effects data

From 2017 Phase 2 trial • 70 Patients • NCT02238626

53%

muscle weakness

41%

Fall

35%

Fatigue

26%

Decreased appetite

21%

nausea

21%

weight decreased

21%

muscle spasms

18%

dyspnea

15%

injury

12%

headache

dysphagia

Ureterolithiasis

pneumonia

intestinal obstruction

Lower limb fracture

Deep vein thrombosis

Hydronephrosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo (for MN-166) (Early ALS Cohort)

MN-166 (Early ALS Cohort)

Placebo (for MN-166) (Advanced ALS Cohort)

MN-166 (Advanced ALS Cohort)

COMBAT-ALS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MN-166Experimental Treatment1 Intervention

Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months.

Group II: placeboPlacebo Group1 Intervention

Subjects will take up to 5 matching placebo capsules twice a day for 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MN-166

2019

Completed Phase 2

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

MediciNovaLead Sponsor

19 Previous Clinical Trials

1,290 Total Patients Enrolled

2 Trials studying Amyotrophic Lateral Sclerosis

105 Patients Enrolled for Amyotrophic Lateral Sclerosis

Kazuko Matsuda, MD PhD MPHStudy DirectorMedicinova Inc

4 Previous Clinical Trials

149 Total Patients Enrolled

Media Library

MN-166 (Phosphodiesterase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04057898 — Phase 2 & 3

Amyotrophic Lateral Sclerosis Research Study Groups: MN-166, placebo

Amyotrophic Lateral Sclerosis Clinical Trial 2023: MN-166 Highlights & Side Effects. Trial Name: NCT04057898 — Phase 2 & 3

MN-166 (Phosphodiesterase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057898 — Phase 2 & 3

Frequently Asked Questions

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

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."

Answered by AI

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"

Answered by AI

Are we still able to enroll people in this experiment?

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

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI