Back to resultsEvaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS (COMBAT-ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MN-166
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, MN-166, ibudilast, amyotrophic lateral sclerosis
Eligibility 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;
- 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 edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug;
- 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:
- Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times upper limit of normal);
- Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms;
- Currently use or treated with parenteral (intramuscular or intravenous) high dose (>25 mg/week) Vitamin B12 within 30 days prior to study drug administration;
- Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
- Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent;
- Use of tracheostomy or >22/24-hour ventilatory support.
Sites / Locations
- University of CaliforniaRecruiting
- Mayo ClinicRecruiting
- Augusta UniversityRecruiting
- Indiana University IU Health Neuroscience CenterRecruiting
- University of Kansas Medical CenterRecruiting
- Johns Hopkins UniversityRecruiting
- Hennepin Healthcare Research InstituteRecruiting
- Mayo Clinic / Rochester
- Hospital for Special Surgery
- SUNY Upstate Medical UniversityRecruiting
- Atrium Health Neurosciences Institute
- Duke UniversityRecruiting
- Providence Brain and Spine Institute
- Lehigh Valley Health NetworkRecruiting
- Allegheny Health Network, Allegheny Neurological AssociatesRecruiting
- University of Virginia Health SystemRecruiting
- Swedish Neuroscience Institute
- University of Alberta HospitalRecruiting
- McMaster University Medical CenterRecruiting
- Sunnybrook Research InstituteRecruiting
- Montreal Neurological Institute and HospitalRecruiting
- Clinique Maladies NeuromusculaireRecruiting
- University of Saskatchewan - Sastakoon HospitalRecruiting
- Hopital de L'Enfant-Jesus, CHU de Quebec-Universite LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MN-166
placebo
Arm Description
Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months.
Subjects will take up to 5 matching placebo capsules twice a day for 12 months.
Outcomes
Primary Outcome Measures
Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.
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
Mean change from baseline of muscle strength measured by hand-held dynamometry
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
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
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
Proportion of subjects in which ALSFRS-R total score was stable or improved.
Time to survival
Defined by death or permanent dependency to ventilator or tracheostomy.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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
Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04057898
Brief Title
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
Acronym
COMBAT-ALS
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediciNova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 followed by an open-label extension phase compared to matching placebo in subjects diagnosed with ALS.
The study will consist of a screening phase (up to 30 days) followed by a double-blind phase (12 months). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to one of two treatment groups: MN-166 or matching placebo in a 1:1 ratio. Upon completion of the double-blind phase, subjects will be given the option to continue to the Open-label Extension Phase for a period of six months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, MN-166, ibudilast, amyotrophic lateral sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MN-166
Arm Type
Experimental
Arm Description
Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take up to 5 matching placebo capsules twice a day for 12 months.
Intervention Type
Drug
Intervention Name(s)
MN-166
Other Intervention Name(s)
ibudilast
Intervention Description
Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase.
Primary Outcome Measure Information:
Title
Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean change from baseline of muscle strength measured by hand-held dynamometry
Description
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.
Time Frame
Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points.
Title
Mean change from baseline on quality of life assessed by ALSAQ-5 at Month 12
Description
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.
Time Frame
12 months
Title
Mean change from baseline of functional activity measured by ALSFRS-R at Month 12
Description
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.
Time Frame
12 months
Title
Responders, measured in percent of subjects overall, whose ALSFRS-R total score was stable or improved
Description
Proportion of subjects in which ALSFRS-R total score was stable or improved.
Time Frame
12 months
Title
Time to survival
Description
Defined by death or permanent dependency to ventilator or tracheostomy.
Time Frame
12 months
Title
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
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.
Time Frame
12 months
Title
Changes from Baseline in Laboratory Values
Description
Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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;
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 edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug;
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:
Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times upper limit of normal);
Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms;
Currently use or treated with parenteral (intramuscular or intravenous) high dose (>25 mg/week) Vitamin B12 within 30 days prior to study drug administration;
Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent;
Use of tracheostomy or >22/24-hour ventilatory support.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Project Management Team
Phone
858-373-1500
Email
clinicaltrialinfo@medicinova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuko Matsuda, MD PhD MPH
Organizational Affiliation
Medicinova Inc
Official's Role
Study Chair
Facility Information:
Facility Name
University of California
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pola Gaid
Phone
714-456-6191
Email
polagaid@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Namita Goyal, MD
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colette McHugh-Strong
Phone
904-953-4965
Email
Mchugh-strong.colette@mayo.edu
First Name & Middle Initial & Last Name & Degree
Jany Paulett
Phone
904-953-3730
Email
Paulett.jany@mayo.edu
First Name & Middle Initial & Last Name & Degree
Bjorn Oskarsson, M.D.
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandy Quarles, MPH CCRC
Phone
706-721-0390
Email
bquarles@augusta.edu
First Name & Middle Initial & Last Name & Degree
Kristy Bouchard, BS CCRC
Phone
706-721-0390
Email
kbouchard@augusta.edu
First Name & Middle Initial & Last Name & Degree
Michael Rivner, MD
Facility Name
Indiana University IU Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Guingrich, LPN
Phone
317-963-7382
Email
sguingri@iu.edu
First Name & Middle Initial & Last Name & Degree
Angela Micheels, PT
Phone
317-963-7382
Email
amicheel@iu.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Bodkin, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katheryn Jennens Lillig
Phone
913-945-9932
Email
kjennens2@kumc.edu
First Name & Middle Initial & Last Name & Degree
Omar Jawdat, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Riley, Ph.D.
Phone
410-955-8511
Email
kriley15@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Alpa Uchil, CRNP
Phone
410-955-8511
Email
apalich2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Nicholas Maragakis, M.D.
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Fruchtman
Phone
612-873-2607
Email
DFruchtman@hhrinstitute.org
First Name & Middle Initial & Last Name & Degree
Sandra Swanson
Phone
612-518-5351
Email
sandyswansonpt@msn.com
First Name & Middle Initial & Last Name & Degree
Samuel Maiser, MD
Facility Name
Mayo Clinic / Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigiriya Smolen
Phone
315-464-1670
Email
smolens@upstate.edu
First Name & Middle Initial & Last Name & Degree
Lena Deb
Phone
315-464-9756
Email
DebL@upstate.edu
First Name & Middle Initial & Last Name & Degree
Jenny Meyer, MD
Facility Name
Atrium Health Neurosciences Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Withdrawn
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel M Ward, RN
Phone
919-613-2681
Email
rachel.m.ward@duke.edu
First Name & Middle Initial & Last Name & Degree
Richard Bedlack, MD
Facility Name
Providence Brain and Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin A Stanley
Phone
610-402-9543
Email
Kevin_A.Stanley@lvhn.org
First Name & Middle Initial & Last Name & Degree
Terry Kloiber, RN
Phone
610-402-9543
Email
Terry.kloiber@lvhn.org
First Name & Middle Initial & Last Name & Degree
Alison Walsh, MD
Facility Name
Allegheny Health Network, Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Nadeo
Email
Miranda.Nadeo@AHN.org
First Name & Middle Initial & Last Name & Degree
Mary Fetter
Email
Mary.Fetter@AHN.org
First Name & Middle Initial & Last Name & Degree
Sandeep Rana, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sejal Smajic
Phone
434-243-0355
Email
SS4YN@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Mary Wagoner
Phone
434-924-5541
Email
Miw9b@virginia.edu
First Name & Middle Initial & Last Name & Degree
Matthew Elliott, MD
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Chen
Email
wei.chen@primesiteresearch.com
First Name & Middle Initial & Last Name & Degree
Kelsey Tymkow
Email
Tymkow@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Wendy Johnston, MD
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Trapsa
Phone
905 521 2100
Ext
76368
Email
trapsd@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Jane Allan
Phone
905 521 2100
Ext
76368
Email
allanjane@HHSC.CA
First Name & Middle Initial & Last Name & Degree
John Turnbull, MD
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nishat Rashid
Phone
416-480-6100
Ext
87561
Email
nishat.rashid@sri.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Jahan Mookshah
Phone
(416) 480-6100
Ext
87561
Email
jahan.mookshah@sri.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Lorne Zinman, MD MSc
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Gobbo
Phone
514-398-6526
Email
Maria.Gobbo@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Vanessa Bertone
Phone
514-398-6183
Email
Vanessa.Bertone@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Angela Genge, MD
Facility Name
Clinique Maladies Neuromusculaire
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Cayer
Phone
819-346-1110
Ext
13920
Email
caroline.cayer.ciusse-chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Caitlyn Bockus
Email
Caitlyn.bockus.ciusse-chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Sylvie Gosselin, MD
Facility Name
University of Saskatchewan - Sastakoon Hospital
City
Saskatoon
State/Province
Saskatchwean
ZIP/Postal Code
S7K 0M7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Boyer
Phone
306-280-8001
Email
Joanne.boyer@usask.ca
First Name & Middle Initial & Last Name & Degree
Kerri Schellenberg, MD
Facility Name
Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Simard
Phone
418-649-0252
Ext
63559
Email
alexandra.simard@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Manon Blanchel
Email
manon.blanchet@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Annie Dionne, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34816762
Citation
Oskarsson B, Maragakis N, Bedlack RS, Goyal N, Meyer JA, Genge A, Bodkin C, Maiser S, Staff N, Zinman L, Olney N, Turnbull J, Brooks BR, Klonowski E, Makhay M, Yasui S, Matsuda K. MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design. Neurodegener Dis Manag. 2021 Dec;11(6):431-443. doi: 10.2217/nmt-2021-0042. Epub 2021 Nov 24.
Results Reference
background
Links:
URL
https://medicinova.com/medicinova-webinar/
Description
This webinar explains the COMBAT-ALS study design and background of MN-166 (ibudilast) as a potential treatment for ALS.
Learn more about this trial
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
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