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Quick Info
Currently Recruiting
2/ 3
Trial Type
Double Blind Placebo Controlled
Treatment Type
Start Date
Contact Information
Canada, Alberta
University of Alberta Hospital, Edmonton, AB, T6G 2G3, Canada
Contact: Wei Chen
Canada, Ontario
McMaster University Medical Center, Hamilton, ON, L8N 3Z5, Canada
Contact: Daniela Trapsa   905 521 2100
Sunnybrook Research Institute, Toronto, ON, M4N 3M5, Canada
Contact: Sonam Dubey   416-480-6860
Canada, Other
Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval, Quebec, G1J 1Z4, Canada
Contact: Alexandra Simard   418-649-0252
University of Saskatchewan - Sastakoon Hospital, Saskatoon, S7K 0M7, Canada
Contact: Twyla Bode   306-655-7742
Canada, Quebec
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
Contact: Mathias Couillard   514-398-6083
Clinique Maladies Neuromusculaire, Sherbrooke, QC, J1H 5N4, Canada
Contact: Caroline Cayer   819-346-1110
United States, California
University of California, Orange, CA, 92868, United States
Contact: Victoria Eon   714-509-2661
United States, Florida
Mayo Clinic, Jacksonville, FL, 32224, United States
Contact: Collette McHugh-Strong   904-953-4965
United States, Georgia
Augusta University, Augusta, GA, 30912, United States
Contact: Brandy Quarles, MPH CCRC   706-721-0390
United States, Indiana
Indiana University IU Health Neuroscience Center, Indianapolis, IN, 46202, United States
Contact: Sandra Guingrich, LPN   317-963-7382
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
Contact: Collin Gerringer   913-574-0008
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21287, United States
Contact: Kristen Riley, Ph.D.   410-955-8511
United States, Minnesota
Hennepin Healthcare Research Institute, Minneapolis, MN, 55415, United States
Contact: Cherie Martinson, BSN   612-873-2607
Mayo Clinic / Rochester, Rochester, MN, 55905, United States
Contact: Michelle Turner   507-284-1223
United States, New York
Hospital for Special Surgery, New York, NY, 10021, United States
Contact: Sharon Holzberg, MS CCC-SLP   646-797-8592
SUNY Upstate Medical University, Syracuse, NY, 13210, United States
Contact: Sigiriya Smolen   315-464-1670
United States, North Carolina
Atrium Health Neurosciences Institute, Charlotte, NC, 28207, United States
Contact: Candace Roberson   704-446-1900
Duke University, Durham, NC, 27705, United States
Contact: Rachel M Ward, RN   919-613-2681
United States, Oregon
Providence Brain and Spine Institute, Portland, OR, 97213, United States
Contact: Ashley Adamo   503-962-1171
United States, Pennsylvania
Lehigh Valley Health Network, Allentown, PA, 18103, United States
Contact: Andrew Orzel, RN   610-402-8447
Allegheny Health Network, Allegheny Neurological Associates, Pittsburgh, PA, 15212, United States
Contact: Mary Fetter   412-359-4856
United States, Virginia
University of Virginia Health System, Charlottesville, VA, 22908, United States
Contact: Sejal Smajic   434-243-0355
United States, Washington
Swedish Neuroscience Institute, Seattle, WA, 98122, United States
Contact: Jennifer Reola   206-320-3695
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
Months Since Onset
Number of months since first symptoms of ALS.
<18 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Open Label
Update Notes
Site added
Site added
Protocol updates
New site added
New site recruiting
Site contact updates
No significant updates
Protocol, site contact updates
No significant updates
Site contacts updated
New site added
New site added
New site added
Updates to site contacts
Updates to site contacts
No significant updates
Updates to site contacts
New site added
New locations added
New locations added
Main contact updated
Locations updated
New locations added
New locations added
New locations added
Updated contact information & new recruitment site added.
No significant changes.
No Significant Changes
New trial added.

Other Information

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.
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:
- ALSFRS-R score of ≤1 on more than one item in the assessment's individual components; - 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.
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.
  • MediciNova
Trial Protocol as Published on
NCT04057898 (First Published: 8/6/2019)