WHO ICTRP trial
A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability…
NL-OMON53858 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON53858 |
|---|---|
| Public title | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) |
| Scientific title | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) - Phase IIIb study of AMX0035 for the treatment of ALS |
| Primary sponsor | Amylyx Pharmaceuticals Inc. |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom;United States of America |
| Conditions | Disease of nerve cells that control muscles Neurodegenerative syndrome;10029317 |
| Interventions | All participants will receive oral (or by feeding tube) treatment with AMX0035 (a fixed dose combination of phenylbutyrate and taurursodiol). All participants will take 2 sachets per day (one dose in the morning and one dose in the evening)… |
| Registration date | Oct 11, 2022 |
| Target size | 25 |
| Secondary IDs | 2022-002348-33;NCT03488524;NL82383.100.22 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: