ALSSEANOBI-ALSNCT06743776
Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS
A study testing MN-166 in people with ALS, run by Mayo Clinic at 15 sites in United States.
Trial summary
The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS
- What is being tested?
- MN-166
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- ALS by "Gold Coast" diagnostic criteria
- Age > 18 years
- Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:
- Time since onset of weakness due to ALS > 36 months
- Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
- Cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
Show all 9Show fewer
- Geographic inaccessibility from nearest actively enrolling research trial site for a trial the patient would otherwise qualify for, defined as either >200 miles or, in the opinion of the investigator, a distance that would make trial participation infeasible for the particular patient, due to significant disease progression or special logistical circumstances. OR II) Former COMBAT-ALS participant or current participant who has completed dosing in the OLE and may be consented at the final OLE follow-up visit.
- Female patients of childbearing potential must use one or more effective methods of contraception throughout the entire EAP and for 30 days after discontinuing MN-166.
- Male patients agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire EAP and for 30 days after discontinuing MN-166.
Who cannot join
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).
- Clinically significant lab abnormalities in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count <2500/mm3, platelet count <75,000/mm3
- Active drug or alcohol abuse
- Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
- Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.
- Concomitant use of prohibited medications. Refer to Program Procedure Manual Appendix 3 for a list of prohibited medications.
- Past participant in COMBAT-ALS clinical trial who did not complete the study.
- Past participant in an ALS research trial who did not complete the study without cause.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Augusta University
Augusta, Georgia, 30912
University of Virginia
Charlottesville, Virginia, 22908
Nova Southeastern University
Davie, Florida, 33314
Duke University
Durham, North Carolina, 27705
Indiana University - IU Health Neuroscience Center
Indianapolis, Indiana, 46202
Mayo Clinic
Jacksonville, Florida, 32224
Semmes Murphey Foundation
Memphis, Tennessee, 38120
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
Hospital for Special Care
New Britain, Connecticut, 06053
UCI Health
Orange, California, 92868
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Mayo Clinic
Scottsdale, Arizona, 85259
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease.
- Conditions
- ALS
- Being tested
- MN-166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN-166Drug
MN-166 will be taken orally at a dose of 10 mg in the morning and 20 mg in the evening for the first 2 weeks, whereafter dose of 30 mg BID will be taken.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- WideTrial, Inc., MediciNova, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Bjorn E. Oskarsson, Mayo Clinic
- Investigators
- Bjorn E Oskarsson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743776
- Sponsor's protocol ID
- 24-009898
- Other IDs
- U01NS136022
- Acronym
- SEANOBI-ALS
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS
- ClinicalTrials.gov ID
- NCT06743776
- Acronym / sponsor ID
- SEANOBI-ALS / 24-009898
- Conditions
- ALS
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- WideTrial, Inc., MediciNova, National Institute of Neurological Disorders and Stroke (NINDS)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ALS by "Gold Coast" diagnostic criteria
- Age > 18 years
- Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:
- Female patients of childbearing potential must use one or more effective methods of contraception throughout the entire EAP and for 30 days after discontinuing MN-166.
- Male patients agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire EAP and for 30 days after discontinuing MN-166.
Key exclusion criteria (8 listed)
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).
- Clinically significant lab abnormalities in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count <2500/mm3, platelet count <75,000/mm3
- Active drug or alcohol abuse
- Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
- Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN-166MN-166 will be taken orally at a dose of 10 mg in the morning and 20 mg in the evening for the first 2 weeks, whereafter dose of 30 mg BID will be taken. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
Related trials for ALS
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjorn E Oskarsson, MD principal investigator
Mayo Clinic
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MN-166 in people with ALS, run by Mayo Clinic at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.