230 Participants Needed

MN-166 for ALS

(COMBAT-ALS Trial)

Recruiting at 21 trial locations
KM
PM
MM
GO
MC
YI
Overseen ByYuichi Iwaki
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are using riluzole or edaravone, you must be on a stable dose or have completed a treatment cycle before starting the study drug.

What data supports the effectiveness of the drug MN-166 (ibudilast) for ALS?

Early-phase studies suggest that MN-166 (ibudilast) may help protect nerve cells and slow down the progression of ALS by reducing inflammation in the brain. However, a trial showed no significant reduction in brain inflammation or nerve damage, and many participants experienced side effects, leading to dose reductions or stopping the drug.12345

Is MN-166 (ibudilast) safe for humans?

In a study with ALS patients, 86% experienced at least one adverse event possibly related to MN-166 (ibudilast), and 31% discontinued due to these events. Some participants could not tolerate the highest dose and required a reduction, indicating that while it has been tested in humans, there are safety concerns at higher doses.23467

What makes the drug MN-166 (ibudilast) unique for treating ALS?

MN-166 (ibudilast) is unique for ALS treatment because it works by reducing inflammation in the brain and spinal cord, which may help protect nerve cells. It does this by inhibiting certain enzymes and proteins that contribute to inflammation and nerve damage, which is different from the limited existing treatments that only slightly prolong survival.24589

Research Team

PM

Project Management Team

Principal Investigator

Medicinova Inc

Eligibility Criteria

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.

Inclusion Criteria

Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted
I have been diagnosed with ALS according to the El Escorial criteria.
My ALS symptoms started less than 18 months ago.
See 6 more

Exclusion Criteria

I have been treated with high dose Vitamin B12 injections recently.
Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator
I use a tracheostomy or need help breathing most of the day.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Double-blind Treatment

Participants receive either MN-166 or placebo for 12 months in a double-blind manner

12 months
Monthly visits (in-person)

Open-label Extension

Participants may opt into continuation of MN-166 treatment for an additional 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MN-166
  • Placebo
Trial OverviewThe 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).
Participant Groups
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.

MN-166 is already approved in Japan for the following indications:

🇯🇵
Approved in Japan as Ibudilast for:
  • Anti-inflammatory

Find a Clinic Near You

Who Is Running the Clinical Trial?

MediciNova

Lead Sponsor

Trials
21
Recruited
1,500+

Findings from Research

The MND-SMART trial aims to evaluate the efficacy of trazodone and memantine in treating motor neuron disease (MND) with up to 531 participants, using a novel adaptive trial design that allows for efficient evaluation of multiple drugs.
The primary outcomes of the trial are the ALS Functional Rating Scale and survival, with the design reducing the time, cost, and number of participants needed to assess drug effectiveness, while minimizing exposure to ineffective treatments.
Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease.Wong, C., Dakin, RS., Williamson, J., et al.[2023]
In a 36-week open-label trial involving 35 ALS participants, ibudilast treatment at doses up to 100 mg/day did not significantly reduce glial activation or neuroaxonal loss, as measured by PBR28-PET and serum Neurofilament light (NfL).
The treatment was associated with a high incidence of adverse events, with 86% of participants experiencing at least one possibly drug-related side effect, leading to dose reductions in 37% of participants and early discontinuation in 31%.
Ibudilast (MN-166) in amyotrophic lateral sclerosis- an open label, safety and pharmacodynamic trial.Babu, S., Hightower, BG., Chan, J., et al.[2023]
Dexpramipexole was found to be safe and well tolerated in a two-part study involving subjects with ALS, with doses of 50, 150, or 300 mg assessed over 12 weeks.
The study showed promising trends indicating that dexpramipexole may slow functional decline in ALS patients, with a statistically significant difference in outcomes related to functional rating and mortality in the second part of the study.
The effects of dexpramipexole (KNS-760704) in individuals with amyotrophic lateral sclerosis.Cudkowicz, M., Bozik, ME., Ingersoll, EW., et al.[2022]

References

Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease. [2023]
Ibudilast (MN-166) in amyotrophic lateral sclerosis- an open label, safety and pharmacodynamic trial. [2023]
The effects of dexpramipexole (KNS-760704) in individuals with amyotrophic lateral sclerosis. [2022]
MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design. [2022]
Phase II screening trial of lithium carbonate in amyotrophic lateral sclerosis: examining a more efficient trial design. [2021]
Safety and efficacy of edaravone compared to historical controls in patients with amyotrophic lateral sclerosis from North-Eastern Italy. [2020]
Analysis of the US Safety Data for Edaravone (Radicava®) From the Third Year After Launch. [2022]
New developments and opportunities in drugs being trialed for amyotrophic lateral sclerosis from 2020 to 2022. [2022]
Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART). [2023]