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Quick Info
Status
Currently Recruiting
Phase
2/ 3
Trial Type
Double Blind Placebo Controlled
Treatment Type
Drug
Randomization
Unknown
Enrollment
230
Start Date
5/28/2020
Sponsor
Contact Information
Locations
Canada, Ontario
McMaster University Medical Center, Hamilton, ON, L8N 3Z5, Canada
Contact: Daniela Trapsa   905 521 2100   trapsd@mcmaster.ca
Sunnybrook Research Institute, Toronto, ON, M4N 3M5, Canada
Contact: Sonam Dubey   416-480-6860   sdubey@sri.utoronto.ca
Canada, Quebec
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
Contact: Mathias Couillard   514-398-6083   Mathias.Couillard@mcgill.ca
United States, California
University of California, Orange, CA, 92868, United States
Contact: Victoria Eon   714-509-2661   eonv@hs.uci.edu
United States, Florida
Mayo Clinic, Jacksonville, FL, 32224, United States
Contact: Megan Donahue   904-953-3726   donahue.megan@mayo.edu
United States, Georgia
Augusta University, Augusta, GA, 30912, United States
Contact: Brandy Quarles, MPH CCRC   706-721-0390   bquarles@augusta.edu
United States, Indiana
Indiana University IU Health Neuroscience Center, Indianapolis, IN, 46202, United States
Contact: Sandra Guingrich, LPN   317-963-7382   sguingri@iu.edu
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
Contact: Collin Gerringer   913-574-0008   cgerringer@kumc.edu
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21287, United States
Contact: Kristen Riley, Ph.D.   410-955-8511   kriley15@jhmi.edu
United States, Minnesota
Hennepin Healthcare Research Institute, Minneapolis, MN, 55415, United States
Contact: Cherie Martinson, BSN   612-873-2607   cmartinson@hhrinstitute.org
Mayo Clinic / Rochester, Rochester, MN, 55905, United States
Contact: Michelle Turner   507-284-1223   Turner.Michelle@mayo.edu
United States, New York
Hospital for Special Surgery, New York, NY, 10021, United States
Contact: Sharon Holzberg, MS CCC-SLP   646-797-8592   Holzbergs@hss.edu
SUNY Upstate Medical University, Syracuse, NY, 13210, United States
Contact: Sigiriya Smolen   315-464-1670   smolens@upstate.edu
United States, North Carolina
Duke University, Durham, NC, 27705, United States
Contact: Rachel M Ward, RN   919-613-2681   rachel.m.ward@duke.edu
United States, Oregon
Providence Brain and Spine Institute, Portland, OR, 97213, United States
Contact: Ashley Adamo   503-962-1171   Ashley.adamo@providence.org
United States, Pennsylvania
Lehigh Valley Health Network, Allentown, PA, 18103, United States
Contact: Andrew Orzel, RN   610-402-8447   Andrew.Orzel@lvhn.org
Allegheny Health Network, Allegheny Neurological Associates, Pittsburgh, PA, 15212, United States
Contact: Mike Bucklaw, CRC   412-359-4776   Mike.Bucklaw@AHN.org
United States, Virginia
University of Virginia Health System, Charlottesville, VA, 22908, United States
Contact: Sejal Smajic   434-243-0355   SS4YN@hscmail.mcc.virginia.edu
United States, Washington
Swedish Neuroscience Institute, Seattle, WA, 98122, United States
Contact: Jennifer Reola   206-320-3695   Jennifer.reola@swedish.org
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>70
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?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
No significant updates
8/31/2021
Protocol, site contact updates
8/12/2021
No significant updates
7/13/2021
Site contacts updated
6/2/2021
New site added
5/21/2021
New site added
4/20/2021
New site added
4/9/2021
Updates to site contacts
3/17/2021
Updates to site contacts
2/23/2021
No significant updates
2/3/2021
Updates to site contacts
1/19/2021
New site added
12/17/2020
New locations added
11/13/2020
New locations added
10/26/2020
Main contact updated
10/20/2020
Locations updated
10/15/2020
New locations added
9/29/2020
New locations added
9/15/2020
New locations added
8/13/2020
Updated contact information & new recruitment site added.
6/1/2020
No significant changes.
3/14/2020
No Significant Changes
8/29/2019
New trial added.
8/15/2019

Other Information

Purpose
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.
Eligibility
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.
Details
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.
Collaborator(s)
  • MediciNova
Trial Protocol as Published on Clinicaltrials.gov
NCT04057898 (First Published: 8/6/2019)