2016-004342-28: A study to compare the absorption into the body of the drug sodium oxybate in FT218 in comparison to the currently marketed product Xyrem®. |
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| Completed | 3 | 24 | Europe | Sodium Oxybate for Extended Release Oral Suspension, Xyrem 500mg/ml oral solution, FT218, Powder for oral suspension, Oral solution, Xyrem® 500mg/ml Oral Solution | Flamel Ireland Ltd trading under the business name Avadel Ireland, Flamel Ireland Limited trading under the business name Avadel Ireland | A trial on healthy volunteer fore the development of a treatment for cataplexy and excessive daytime sleepiness in narcolepsy., Cataplexy is an abrupt temporary loss of voluntary muscular function and tone. Narcolepsy which is an neurological disorder that affects the control of sleep and wakefulness., Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
| Completed | 3 | 184 | Canada, US | FT218 | Avadel | Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders | 12/23 | 11/24 | | |
| Recruiting | 2 | 36 | US | Extended-release sodium oxybate, Lumryz, Non-extended-release oxybates, Xywav, Xyrem | Stanford University, Avadel | Narcolepsy Type 1 (NT 1) | 06/27 | 07/27 | | |
