Open Label Extension Study of AMX0035 in Patients With ALS
Purpose
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.
Conditions
- Amyotrophic Lateral Sclerosis
- ALS
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. 2. Must enroll in the OLE within 28 days of the Week 24 visit of the main study. 3. Signed informed consent to enter the open label extension phase.
Exclusion Criteria
- Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV. 2. Exposure to or anticipated requirement for any disallowed medication listed below. 3. Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug. 4. Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study 5. Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This an open-label extension study to CENTAUR (AMX-3500)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AMX0035 |
AMX0035 twice daily--a combination therapeutic including 3 gram of Phenylbutyrate and 1g TUDCA |
|
More Details
- Status
- Completed
- Sponsor
- Amylyx Pharmaceuticals Inc.
Study Contact
Detailed Description
The Centaur Open Label Extension Study (CENTAUR-OLE) is designed to provide longer term access to AMX0035 for patients with ALS who participated in the CENTAUR study. The study will assess longer term safety and therapeutic potential of AMX0035.