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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
Must not have
Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times upper limit of normal)
Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, treatment phase week 6, months 3, 6, 9 and12 time points.

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ALS according to the El Escorial criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver isn't working properly (high AST or ALT levels).
Select...
I do not have a psychiatric disorder or dementia that affects my ability to evaluate symptoms.
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I have been treated with high dose Vitamin B12 injections recently.
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I use a tracheostomy or need help breathing most of the day.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.
Secondary study objectives
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
9%
dysphagia
3%
intestinal obstruction
3%
pneumonia
3%
Lower limb fracture
3%
Hydronephrosis
3%
Ureterolithiasis
3%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
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)

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

Find a Location

Who is running the clinical trial?

MediciNovaLead Sponsor
20 Previous Clinical Trials
1,284 Total Patients Enrolled
3 Trials studying Amyotrophic Lateral Sclerosis
105 Patients Enrolled for Amyotrophic Lateral Sclerosis
Project Management TeamStudy ChairMedicinova Inc
Kazuko Matsuda, MD PhD MPHStudy DirectorMedicinova Inc
4 Previous Clinical Trials
143 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
~38 spots leftby Dec 2025
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