Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS (COMBAT-ALS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04057898|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: MN-166 Drug: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis|
|Actual Study Start Date :||May 28, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day, along with a stable dose of riluzole, daily for 12 months.
Subjects will take MN-166 with a stable dose of riluzole for 12 months followed by a 6-month open-label extension phase.
Other Name: ibudilast
Placebo Comparator: placebo
Subjects will take up to 5 matching placebo capsules twice a day, along with a stable dose of riluzole, daily for 12 months.
Subjects will take matching placebo with a stable dose of riluzole for 12 months followed by a 6-month open-label extension phase.
- Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time. [ Time Frame: 12 months ]The amyotrophic lateral sclerosis functional rating scale-revised, or ALSFRS-R, measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points.
- Mean change from baseline of muscle strength measured by hand-held dynamometry [ Time Frame: Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points. ]Hand-held dynamometry, or HHD, is used to measure the force generated by each muscle. The scale ranges from 0 (no visible movement of the part) to 10 (holds test position against strong pressure). Thus, the higher the total score, the higher muscle strength is observed.
- Mean change from baseline on quality of life assessed by ALSAQ-5 at Month 12 [ Time Frame: 12 months ]The Amyotrophic Lateral Sclerosis Assessment Questionnaire, or ALSAQ-5, is a patient self-report questionnaire specifically designed to measure 5 areas of health: physical mobility, activities of daily living and independence, eating and drinking, communication and emotional functioning. The subject is asked about 5 different areas of difficulties in their daily lives: ability to stand up, use of limbs, consuming solid food, level of speech coherence, and degree of hope about the future.Each question provides 5 choices from which to choose: Never, Rarely, Sometimes, Often, and Always or cannot do at all.
- Mean change from baseline of functional activity measured by ALSFRS-R at Month 12 [ Time Frame: 12 months ]The ALSFRS-R assessment tool measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points. In this context, the ALSFRS-R total score change (lower, same, higher) is documented.
- Responders, measured in percent of subjects overall, whose ALSFRS-R total score was stable or improved [ Time Frame: 12 months ]Proportion of subjects in which ALSFRS-R total score was stable or improved.
- Time to survival [ Time Frame: 12 months ]Defined by death or permanent dependency to ventilator or tracheostomy.
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 12 months ]The incidence of treatment-emergent adverse events (TEAEs), severity (mild, moderate, severe), as well as relationship to study treatment (not related, possibly related, probably related) and whether they are considered serious.
- Changes from Baseline in Laboratory Values [ Time Frame: 12 months ]Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057898
|Contact: Joanna Dojillo, MMSc||858-373-1500 ext firstname.lastname@example.org|
|United States, California|
|University of California||Recruiting|
|Orange, California, United States, 92868|
|Contact: Victoria Eon 714-509-2661 email@example.com|
|Contact: Shannon Ung (714) 456-6526 firstname.lastname@example.org|
|Principal Investigator: Namita Goyal, MD|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Contact: Jany Paulett 904-953-3730 Paulett.Jany@mayo.edu|
|Contact: Megan Donahue 904-953-3647 email@example.com|
|Principal Investigator: Bjorn Oskarsson, M.D.|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Contact: Brandy Quarles, MPH 706-721-0390 firstname.lastname@example.org|
|Contact: Kristy Bouchard 706-721-0390 email@example.com|
|Principal Investigator: Michael Rivner, MD|
|Sub-Investigator: Diane Manghram, MD|
|United States, Indiana|
|Indiana University IU Health Neuroscience Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Sandra Guingrich, LPN 317-963-7382 firstname.lastname@example.org|
|Contact: Angela Micheels, PT 317-963-7382|
|Principal Investigator: Cynthia Bodkin, MD|
|Sub-Investigator: Robert Pascuzzi, MD|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kristen Riley, Ph.D. 410-955-8511 email@example.com|
|Contact: Alpa Uchill, CRNP 410-955-8511 firstname.lastname@example.org|
|Principal Investigator: Nicholas Maragakis, M.D.|
|United States, New York|
|SUNY Upstate Medical University||Recruiting|
|Syracuse, New York, United States, 12310|
|Contact: Muhammad M Iqbal, CCRC 315-464-1814 email@example.com|
|Contact: Jacob Pusey, BS 315-464-9767 PuseyJ@upstate.edu|
|Principal Investigator: Jenny Meyer, MD|
|Sub-Investigator: Eufrosina Young, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Lisa Harrison, RN 919-613-2681 Lisa.firstname.lastname@example.org|
|Contact: Debra Heydt, RN 919-668-2843 Debra.email@example.com|
|Principal Investigator: Richard Bedlack, MD|
|United States, Oregon|
|Providence Brain and Spine Institute||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Arlena Cummings, CCRP 503-962-1171 Arlena.firstname.lastname@example.org|
|Contact: Lauren Brown, RN 503-962-1173 Lauren.email@example.com|
|Principal Investigator: Nicholas Olney, MD|
|Sub-Investigator: Kimberly Goslin, MD|
|United States, Pennsylvania|
|Allegheny Health Network, Allegheny Neurological Associates||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15212|
|Contact: Patricia Blenk 412-359-6412 Patricia.Blenk@AHN.org|
|Contact: Mary Fetter 412-359-4856 Mary.Fetter@AHN.org|
|Principal Investigator: Sandeep Rana, MD|
|Sub-Investigator: George Small, MD|
|Sub-Investigator: Timothy Quezada, DO|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Mary Wagoner 434-924-5541 Miw9b@virginia.edu|
|Contact: Deborah Eggleston, MSN, RN 434-924-5541 Dse3c@virginia.edu|
|Principal Investigator: Goran Rakocevic, MD|
|Sub-Investigator: Matthew Elliott, MD|
|Montreal Neurological Institute and Hospital||Recruiting|
|Montreal, Quebec, Canada, H3A 2B4|
|Contact: Natalie Saunders, M.Sc.A.OT. 514-398-6526 Natalie.firstname.lastname@example.org|
|Contact: Juliette Foucher, M.Sc. 514-398-6188 Juliette.email@example.com|
|Study Chair:||Kazuko W Matsuda, MD PhD MPH||Medicinova Inc|