Study 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.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MN-166, placebo
Placebo:
Yes
Phase:
Phase 2/Phase 3
Study Chair(s)/Principal Investigator(s):
Kazuko Matsuda, MD PhD MPH, Medicinova Inc
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Project Management Team / email hidden; JavaScript is required / 858-373-1500
United States
Full Study Summary:
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.
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.
Study Sponsor:
MediciNova
Estimated Enrollment:
230
Estimated Study Start Date:
05 / 28 / 2020
Estimated Study Completion Date:
12 / 01 / 2024
Posting Last Modified Date:
03 / 21 / 2023
Date Study Added to neals.org:
08 / 15 / 2019
Minimum Age:
18 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
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.
University of California | Recruiting
Pola Gaid / 714-456-6191 / email hidden; JavaScript is required
Principal Investigator : Namita Goyal, MD
Orange, California
92868
United States
Mayo Clinic | Recruiting
Collette McHugh-Strong / 904-953-4965 / email hidden; JavaScript is required
Jany Paulett / 904-953-3730 / email hidden; JavaScript is required
Principal Investigator : Bjorn Oskarsson, M.D.
Jacksonville, Florida
32224
United States
Augusta University | Recruiting
Brandy Quarles, MPH CCRC / 706-721-0390 / email hidden; JavaScript is required
Kristy Bouchard, BS CCRC / 706-721-0390 / email hidden; JavaScript is required
Principal Investigator : Michael Rivner, MD
Augusta, Georgia
30912
United States
Indiana University IU Health Neuroscience Center | Recruiting
Sandra Guingrich, LPN / 317-963-7382 / email hidden; JavaScript is required
Angela Micheels, PT / 317-963-7382 / email hidden; JavaScript is required
Principal Investigator : Cynthia Bodkin, MD
Indianapolis, Indiana
46202
United States
University of Kansas Medical Center | Recruiting
Collin Gerringer / 913-574-0008 / email hidden; JavaScript is required
Katheryn Jennens / 913-945-9932 / email hidden; JavaScript is required
Principal Investigator : Omar Jawdat, MD
Kansas City, Kansas
66160
United States
Johns Hopkins University | Recruiting
Kristen Riley, Ph.D. / 410-955-8511 / email hidden; JavaScript is required
Alpa Uchil, CRNP / 410-955-8511 / email hidden; JavaScript is required
Principal Investigator : Nicholas Maragakis, M.D.
Baltimore, Maryland
21287
United States
Hennepin Healthcare Research Institute | Recruiting
Daphne Fruchtman / 612-873-2607 / email hidden; JavaScript is required
Sandra Swanson / 612-518-5351 / email hidden; JavaScript is required
Principal Investigator : Samuel Maiser, MD
Minneapolis, Minnesota
55415
United States
Mayo Clinic / Rochester | Withdrawn
Rochester, Minnesota
55905
United States
Hospital for Special Surgery | Withdrawn
New York, New York
10021
United States
SUNY Upstate Medical University | Recruiting
Sigiriya Smolen / 315-464-1670 / email hidden; JavaScript is required
Lena Deb / 315-464-9756 / email hidden; JavaScript is required
Principal Investigator : Jenny Meyer, MD
Syracuse, New York
13210
United States
Atrium Health Neurosciences Institute | Recruiting
Candace Roberson / 704-446-1900 / email hidden; JavaScript is required
Principal Investigator : Leo McCluskey, MD
Charlotte, North Carolina
28207
United States
Duke University | Recruiting
Rachel M Ward, RN / 919-613-2681 / email hidden; JavaScript is required
Principal Investigator : Richard Bedlack, MD
Durham, North Carolina
27705
United States
Providence Brain and Spine Institute | Withdrawn
Portland, Oregon
97213
United States
Lehigh Valley Health Network | Recruiting
Andrew Orzel, RN / 610-402-8447 / email hidden; JavaScript is required
Terry Kloiber, RN / 610-402-9543 / email hidden; JavaScript is required
Principal Investigator : Alison Walsh, MD
Allentown, Pennsylvania
18103
United States
Allegheny Health Network, Allegheny Neurological Associates | Recruiting
Miranda Nadeo / email hidden; JavaScript is required
Mary Fetter / email hidden; JavaScript is required
Principal Investigator : Sandeep Rana, MD
Pittsburgh, Pennsylvania
15212
United States
University of Virginia Health System | Recruiting
Sejal Smajic / 434-243-0355 / email hidden; JavaScript is required
Mary Wagoner / 434-924-5541 / email hidden; JavaScript is required
Principal Investigator : Matthew Elliott, MD
Charlottesville, Virginia
22908
United States
Swedish Neuroscience Institute | Withdrawn
Seattle, Washington
98122
United States
University of Alberta Hospital | Recruiting
Wei Chen / email hidden; JavaScript is required
Kelsey Tymkow / email hidden; JavaScript is required
Principal Investigator : Wendy Johnston, MD
Edmonton, Alberta
T6G 2G3
Canada
McMaster University Medical Center | Recruiting
Daniela Trapsa / 905 521 2100 Ext. 76368 / email hidden; JavaScript is required
Jane Allan / 905 521 2100 Ext. 76368 / email hidden; JavaScript is required
Principal Investigator : John Turnbull, MD
Hamilton, Ontario
L8N 3Z5
Canada
Sunnybrook Research Institute | Recruiting
Nishat Rashid / 416-480-6100 Ext. 87561 / email hidden; JavaScript is required
Jahan Mookshah / (416) 480-6100 Ext. 87561 / email hidden; JavaScript is required
Principal Investigator : Lorne Zinman, MD MSc
Toronto, Ontario
M4N 3M5
Canada
Montreal Neurological Institute and Hospital | Recruiting
Achraf Boutayeb / 514-398-6083 / email hidden; JavaScript is required
Vanessa Bertone / 514-398-6183 / email hidden; JavaScript is required
Principal Investigator : Angela Genge, MD
Montreal, Quebec
H3A 2B4
Canada
Clinique Maladies Neuromusculaire | Recruiting
Caroline Cayer / 819-346-1110 Ext. 13920 / email hidden; JavaScript is required
Caitlyn Bockus / email hidden; JavaScript is required
Principal Investigator : Sylvie Gosselin, MD
Sherbrooke, Quebec
J1H 5N4
Canada
University of Saskatchewan - Sastakoon Hospital | Recruiting
Twyla Bode / 306-655-7742 / email hidden; JavaScript is required
Joanne Boyer / email hidden; JavaScript is required
Principal Investigator : Kerri Schellenberg, MD
Saskatoon, Saskatchwean
S7K 0M7
Canada
Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval | Recruiting
Alexandra Simard / 418-649-0252 Ext. 63559 / email hidden; JavaScript is required
Manon Blanchel / email hidden; JavaScript is required
Principal Investigator : Annie Dionne, MD
Quebec G1J 1Z4
Canada