AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Description

The CENTAUR trial will be a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.

Study Start Date

June, 22 2017

Estimated Completion Date

May 2019

Interventions

  • Other: Placebo
  • Drug: AMX0035

Study ID

Amylyx Pharmaceuticals Inc. -- AMX-3500

Status

Recruiting

Trial ID

NCT03127514

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

132

Sponsor

Amylyx Pharmaceuticals Inc.

Key

Inclusion Criteria

    1. Male or female, aged 18-80 years of age 2. Sporadic or familial ALS diagnosed as definite as defined by the World Federation of Neurology revised El Escorial criteria 3. Less than or equal to 18 months since ALS symptom onset 4. Capable of providing informed consent and following trial procedures 5. Slow Vital Capacity (SVC) >60% of predicted value for gender, height, and age at the Screening Visit 6. Subjects must either not take riluzole or be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole-naïve subjects are permitted in the study. 7. Women of child bearing potential (e.g. not post-menopausal for at least one year or surgically sterile) must agree to use adequate birth control for the duration of the study and 3 months after last dose of study drug. Women must not be planning to become pregnant for the duration of the study and 3 months after last dose of study drug 8. Men must agree to practice contraception for the duration of the study and 3 months after last dose of study drug. Men must not plan to father a child or provide for sperm donation for the duration of the study and 3 months after last dose of study drug Key

Exclusion Criteria

    1. Presence of tracheostomy 2. Exposure to PB, TUDCA or UDCA within 3 months prior to the Screening Visit or planning to use these medications during the course of the study 3. History of known allergy to PB or bile salts 4. Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the normal 5. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal 6. Poorly controlled arterial hypertension (SBP>160mmHg or DBP>100mmHg) at the Screening Visit 7. Pregnant women or women currently breastfeeding 8. History of cholecystectomy 9. Biliary disease which impedes biliary flow including active cholecystitis, primary biliary cirrhosis, sclerosing cholangitis, gallbladder cancer, gallbladder polyps, gangrene of the gallbladder, abscess of the gallbladder. 10. History of Class III/IV heart failure (per New York Heart Association
  • NYHA) 11. Severe pancreatic or intestinal disorders that may alter the enterohepatic circulation and absorption of TUDCA including biliary infections, pancreatitis and ileal resection 12. The presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the subject to provide informed consent, according to Site Investigator judgment 13. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the subject if they were to participate in the study 14. Active participation in an ALS clinical trial evaluating a small molecule within 30 days of the Screening Visit 15. Exposure at any time to any biologic under investigation for the treatment of subjects with ALS (off-label use or investigational) including cell therapies, gene therapies, and monoclonal antibodies. 16. Implantation of Diaphragm Pacing System (DPS)

Gender

All

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (106)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aileen Shaughnessy MA 617-724-9196 ANSHAUGHNESSY@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aileen Shaughnessy MA 617-724-9196 ANSHAUGHNESSY@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aileen Shaughnessy MA 617-724-9196 ANSHAUGHNESSY@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aileen Shaughnessy MA 617-724-9196 ANSHAUGHNESSY@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aileen Shaughnessy MA 617-724-9196 ANSHAUGHNESSY@mgh.harvard.edu
University of Massachusetts Memorial Medical Center - Worcester, Massachusetts 34.2 miles Diane McKennaYasek RN BSN 508-856-4697 diane.mckenna-yasek@umassmed.edu
University of Massachusetts Memorial Medical Center - Worcester, Massachusetts 34.2 miles Diane McKennaYasek RN BSN 508-856-4697 diane.mckenna-yasek@umassmed.edu
University of Massachusetts Memorial Medical Center - Worcester, Massachusetts 34.2 miles Diane McKennaYasek RN BSN 508-856-4697 diane.mckenna-yasek@umassmed.edu
University of Massachusetts Memorial Medical Center - Worcester, Massachusetts 34.2 miles Diane McKennaYasek RN BSN 508-856-4697 diane.mckenna-yasek@umassmed.edu
University of Massachusetts Memorial Medical Center - Worcester, Massachusetts 34.2 miles Diane McKennaYasek RN BSN 508-856-4697 diane.mckenna-yasek@umassmed.edu
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Temple University Hospital - Philadelphia, Pennsylvania 266.2 miles None None None
Temple University Hospital - Philadelphia, Pennsylvania 266.2 miles None None None
Temple University Hospital - Philadelphia, Pennsylvania 266.2 miles None None None
Temple University Hospital - Philadelphia, Pennsylvania 266.2 miles None None None
Temple University Hospital - Philadelphia, Pennsylvania 266.2 miles None None None
The Penn Comprehensive ALS Center - Philadelphia, Pennsylvania 269.5 miles None None None
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kristen Riley PhD 410-955-9036 kriley15@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kristen Riley PhD 410-955-9036 kriley15@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kristen Riley PhD 410-955-9036 kriley15@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kristen Riley PhD 410-955-9036 kriley15@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kristen Riley PhD 410-955-9036 kriley15@jhmi.edu
The Ohio State University Wexner Medical Center - Columbus, Ohio 644.2 miles None None None
The Ohio State University Wexner Medical Center - Columbus, Ohio 644.2 miles None None None
The Ohio State University Wexner Medical Center - Columbus, Ohio 644.2 miles None None None
The Ohio State University Wexner Medical Center - Columbus, Ohio 644.2 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 645.2 miles None None None
Wake Forest Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Meha Joshi BS 859-218-5046 majo235@uky.edu
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Meha Joshi BS 859-218-5046 majo235@uky.edu
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Meha Joshi BS 859-218-5046 majo235@uky.edu
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Meha Joshi BS 859-218-5046 majo235@uky.edu
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Meha Joshi BS 859-218-5046 majo235@uky.edu
Emory University Hospital - Atlanta, Georgia 932.0 miles None None None
Emory University Hospital - Atlanta, Georgia 932.0 miles None None None
Emory University Hospital - Atlanta, Georgia 932.0 miles None None None
Washington University Medical Center - Saint Louis, Missouri 1,039.5 miles None None None
Washington University Medical Center - Saint Louis, Missouri 1,039.5 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,050.4 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,050.4 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,050.4 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,050.4 miles None None None
University of Florida Medical Center - Gainesville, Florida 1,081.3 miles Jennifer Steshyn MABMH CCRP 352-273-9022 jennifer.steshyn@neurology.ufl.edu
University of Florida Medical Center - Gainesville, Florida 1,081.3 miles Jennifer Steshyn MABMH CCRP 352-273-9022 jennifer.steshyn@neurology.ufl.edu
University of Florida Medical Center - Gainesville, Florida 1,081.3 miles Jennifer Steshyn MABMH CCRP 352-273-9022 jennifer.steshyn@neurology.ufl.edu
University of Florida Medical Center - Gainesville, Florida 1,081.3 miles Jennifer Steshyn MABMH CCRP 352-273-9022 jennifer.steshyn@neurology.ufl.edu
University of Florida Medical Center - Gainesville, Florida 1,081.3 miles Jennifer Steshyn MABMH CCRP 352-273-9022 jennifer.steshyn@neurology.ufl.edu
Hennepin County Medical Center - Minneapolis, Minnesota 1,121.1 miles Cindy Rohde 612-873-2607 cindy.rohde@hcmed.org
Hennepin County Medical Center - Minneapolis, Minnesota 1,121.1 miles Cindy Rohde 612-873-2607 cindy.rohde@hcmed.org
Hennepin County Medical Center - Minneapolis, Minnesota 1,121.1 miles Cindy Rohde 612-873-2607 cindy.rohde@hcmed.org
Hennepin County Medical Center - Minneapolis, Minnesota 1,121.1 miles Cindy Rohde 612-873-2607 cindy.rohde@hcmed.org
Carol and Frank Morsini Center for Advanced Health Care University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 bharvey1@health.usf.edu
Carol and Frank Morsini Center for Advanced Health Care University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 bharvey1@health.usf.edu
Carol and Frank Morsini Center for Advanced Health Care University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 bharvey1@health.usf.edu
Carol and Frank Morsini Center for Advanced Health Care University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 bharvey1@health.usf.edu
Carol and Frank Morsini Center for Advanced Health Care University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 bharvey1@health.usf.edu
Neurology Associates PC - Lincoln, Nebraska 1,323.5 miles None None None
Neurology Associates PC - Lincoln, Nebraska 1,323.5 miles None None None
Neurology Associates PC - Lincoln, Nebraska 1,323.5 miles None None None
Neurology Associates PC - Lincoln, Nebraska 1,323.5 miles None None None
Neurology Associates PC - Lincoln, Nebraska 1,323.5 miles None None None
Ochsner Neuroscience Institute - New Orleans, Louisiana 1,363.3 miles Ashley Laroche 504-703-0755 ashley.laroche@ocshner.org
Ochsner Neuroscience Institute - New Orleans, Louisiana 1,363.3 miles Ashley Laroche 504-703-0755 ashley.laroche@ocshner.org
Ochsner Neuroscience Institute - New Orleans, Louisiana 1,363.3 miles Ashley Laroche 504-703-0755 ashley.laroche@ocshner.org
Ochsner Neuroscience Institute - New Orleans, Louisiana 1,363.3 miles Ashley Laroche 504-703-0755 ashley.laroche@ocshner.org
Texas Neurology PA - Dallas, Texas 1,546.8 miles Todd Morgan BS 214-827-3610 tmorgan@texasneurology.com
Texas Neurology PA - Dallas, Texas 1,546.8 miles Todd Morgan BS 214-827-3610 tmorgan@texasneurology.com
Texas Neurology PA - Dallas, Texas 1,546.8 miles Todd Morgan BS 214-827-3610 tmorgan@texasneurology.com
Texas Neurology PA - Dallas, Texas 1,546.8 miles Todd Morgan BS 214-827-3610 tmorgan@texasneurology.com
Texas Neurology PA - Dallas, Texas 1,546.8 miles Todd Morgan BS 214-827-3610 tmorgan@texasneurology.com
University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,768.2 miles Pamela Kittrell RN MSN CCRC 210-450-0524 Kittrellp@uthscsa.edu
University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,768.2 miles Pamela Kittrell RN MSN CCRC 210-450-0524 Kittrellp@uthscsa.edu
University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,768.2 miles Pamela Kittrell RN MSN CCRC 210-450-0524 Kittrellp@uthscsa.edu
University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,768.2 miles Pamela Kittrell RN MSN CCRC 210-450-0524 Kittrellp@uthscsa.edu
University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,768.2 miles Pamela Kittrell RN MSN CCRC 210-450-0524 Kittrellp@uthscsa.edu
Barrow Neurological Institute - Phoenix, Arizona 2,297.3 miles None None None
ALS Center at the Swedish Neuroscience Institute - Seattle, Washington 2,488.3 miles Lindsey Maassel MS 206-320-7121 lindsey.maassel@swedish.org
ALS Center at the Swedish Neuroscience Institute - Seattle, Washington 2,488.3 miles Lindsey Maassel MS 206-320-7121 lindsey.maassel@swedish.org
ALS Center at the Swedish Neuroscience Institute - Seattle, Washington 2,488.3 miles Lindsey Maassel MS 206-320-7121 lindsey.maassel@swedish.org
ALS Center at the Swedish Neuroscience Institute - Seattle, Washington 2,488.3 miles Lindsey Maassel MS 206-320-7121 lindsey.maassel@swedish.org
ALS Center at the Swedish Neuroscience Institute - Seattle, Washington 2,488.3 miles Lindsey Maassel MS 206-320-7121 lindsey.maassel@swedish.org
Oregon Health Science University - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University - Portland, Oregon 2,538.3 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
Forbes Norris MDAALS Research Center California Pacific Medical Center - San Francisco, California 2,698.8 miles None None None
Forbes Norris MDAALS Research Center California Pacific Medical Center - San Francisco, California 2,698.8 miles None None None
Forbes Norris MDAALS Research Center California Pacific Medical Center - San Francisco, California 2,698.8 miles None None None
Forbes Norris MDAALS Research Center California Pacific Medical Center - San Francisco, California 2,698.8 miles None None None
Forbes Norris MDAALS Research Center California Pacific Medical Center - San Francisco, California 2,698.8 miles None None None

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