Study Summary
This trial is testing a potential ALS treatment. It will last 18 months and compare the drug to a placebo.
- ALS (Amyotrophic Lateral Sclerosis)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points.
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
MN-166
1 of 2
placebo
1 of 2
Experimental Treatment
Non-Treatment Group
230 Total Participants · 2 Treatment Groups
Primary Treatment: MN-166 · Has Placebo Group · Phase 2 & 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Oskarsson, Björn, Nicholas Maragakis, Richard S Bedlack, Namita Goyal, Jenny A Meyer, Angela Genge, Cynthia Bodkin, et al.. 2021. “MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis in a Phase Iib/iii Study: COMBAT-ALS Study Design”. Neurodegenerative Disease Management. Future Medicine Ltd. doi:10.2217/nmt-2021-0042.
- Oskarsson, Björn, Nicholas Maragakis, Richard S Bedlack, Namita Goyal, Jenny A Meyer, Angela Genge, Cynthia Bodkin, et al.. 2021. “MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis in a Phase Iib/iii Study: COMBAT-ALS Study Design”. Neurodegenerative Disease Management. Future Medicine Ltd. doi:10.2217/nmt-2021-0042.
- Oskarsson, Björn, Nicholas Maragakis, Richard S Bedlack, Namita Goyal, Jenny A Meyer, Angela Genge, Cynthia Bodkin, et al.. 2021. “MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis in a Phase Iib/iii Study: COMBAT-ALS Study Design”. Neurodegenerative Disease Management. Future Medicine Ltd. doi:10.2217/nmt-2021-0042.
- 2020. "Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04057898.
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
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
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." - Anonymous Online Contributor
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
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
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
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