Open Label Extension Study of AMX0035 in Patients With ALS (CENTAUR-OLE)
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|ClinicalTrials.gov Identifier: NCT03488524|
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : January 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis ALS||Drug: AMX0035||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This an open-label extension study to CENTAUR (AMX-3500)|
|Masking:||None (Open Label)|
|Official Title:||Open Label Extension Study of AMX0035 in Patients With ALS|
|Actual Study Start Date :||March 29, 2018|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||November 1, 2021|
AMX0035 twice daily--a combination therapeutic including 3 gram of Phenylbutyrate and 1g TUDCA
A combination therapeutic of TUDCA and Sodium Phenylbutyrate
- Quantity of adverse events and serious adverse events observed in the study [ Time Frame: 30 months ]Quantity of adverse events and serious adverse events observed in the study
- Hospitalizations [ Time Frame: 30 months ]Number of Hospitalizations
- Rate of Progression on the Amyotrophic Lateral Sclerosis Rating Scale Revised (ALSFRS-R) [ Time Frame: 30 months ]Slope of Progression on ALSFRS-R
- Rate of Progression on ATLIS Strength Measurement [ Time Frame: 30 months ]Rate of progression in strength measurements by ATLIS
- Rate of Progression on Slow Vital Capacity [ Time Frame: 30 months ]Rate of change in breathing capabilities by slow vital capacity
- Gastric Tube Frequency [ Time Frame: 30 months ]Number of Gastric Tubes Placed
- Permanent Invasive Ventilation [ Time Frame: 30 months ]Number of patients of permanent invasive ventilation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Completion of all visits in the randomized, double blind AMX0035 study. Subjects that receive tracheostomy or PAV during the course of the main study will still be followed as ITT until the week 24 visit before enrollment in the OLE.
- Must enroll in the OLE within 28 days of the Week 24 visit of the main study.
- Signed informed consent to enter the open label extension phase.
- Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV.
- Exposure to or anticipated requirement for any disallowed medication listed below.
- Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug.
- Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study
- Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488524
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|University of Massachusetts Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|Responsible Party:||Amylyx Pharmaceuticals Inc.|
|Other Study ID Numbers:||
|First Posted:||April 5, 2018 Key Record Dates|
|Last Update Posted:||January 10, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases