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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
Sponsor:
Information provided by (Responsible Party):
MediciNova

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: MN-166 Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: MN-166
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.
Drug: MN-166
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.
Drug: placebo
Subjects will take matching placebo with a stable dose of riluzole for 12 months followed by a 6-month open-label extension phase.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Time to survival [ Time Frame: 12 months ]
    Defined by death or permanent dependency to ventilator or tracheostomy.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Male or female subjects age 18 - 80 years, inclusive;
  • 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;
  • Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug;
  • If currently using edaravone, subject should have completed at least one cycle of edaravone prior to Screening visit;
  • Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted;;
  • Able to swallow study medication capsules;
  • No known allergies to the study drug or its excipients;
  • Received pneumococcal vaccine within 6 years prior to starting clinical trial.

Major Exclusion Criteria:

  • ALSFRS-R score of ≤1 on more than one item in the assessment's individual components;
  • Currently use or treated with Nuedexta® ≤3 months prior to signing consent;
  • Currently use or treated with Methylcobalamin Vitamin B12 ≤3 months prior to signing consent
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
  • Use of tracheostomy or >22/24-hour ventilatory support.

Information from the National Library of Medicine

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


Contacts
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Contact: Joanna Dojillo, MMSc 858-373-1500 ext 118 dojillo@medicinova.com

Locations
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United States, California
University of California Recruiting
Orange, California, United States, 92868
Contact: Victoria Eon    714-509-2661    eonv@hs.uci.edu   
Contact: Shannon Ung    (714) 456-6526    ungsa@hs.uci.edu   
Principal Investigator: Namita Goyal, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jany Paulett    904-953-3730    Paulett.Jany@mayo.edu   
Contact: Megan Donahue    904-953-3647    donahue.megan@mayo.edu   
Principal Investigator: Bjorn Oskarsson, M.D.         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Brandy Quarles, MPH    706-721-0390    bquarles@augusta.edu   
Contact: Kristy Bouchard    706-721-0390    kbouchard@augusta.edu   
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    sguingri@iu.edu   
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    kriley15@jhmi.edu   
Contact: Alpa Uchill, CRNP    410-955-8511    apalich2@jhmi.edu   
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    iqbalmuh@upstate.edu   
Contact: Jacob Pusey, BS    315-464-9767    PuseyJ@upstate.edu   
Principal Investigator: Jenny Meyer, MD         
Sub-Investigator: Eufrosina Young, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Lisa Harrison, RN    919-613-2681    Lisa.harrison@duke.edu   
Contact: Debra Heydt, RN    919-668-2843    Debra.heydt@duke.edu   
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.cummings@providence.org   
Contact: Lauren Brown, RN    503-962-1173    Lauren.brown3@providence.org   
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         
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Natalie Saunders, M.Sc.A.OT.    514-398-6526    Natalie.saunders@mcgill.ca   
Contact: Juliette Foucher, M.Sc.    514-398-6188    Juliette.foucher@mcgill.ca   
Sponsors and Collaborators
MediciNova
Investigators
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Study Chair: Kazuko W Matsuda, MD PhD MPH Medicinova Inc
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Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT04057898    
Other Study ID Numbers: MN-166-ALS-2301
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MediciNova:
ALS
MN-166
ibudilast
amyotrophic lateral sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents