2007-002074-58: Estudio unicéntrico, aleatorizado, doble ciego, de diseño cruzado, controlado con placebo, de nueve semanas de duracion para evaluar la eficacia de oxibato sodico en pacientes con el síndrome de las piernas inquietas idiopático (SPI). |
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| Ongoing | 3 | 25 | Europe | XYREM, XYREM | Instituto de Investigaciones del Sueño | El Síndrome de las piernas inquietas idiopático (SPI) | | | | |
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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| Ongoing | 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] | | | | |
2017-004122-15: A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of sodium oxybate in patients affected with idiopathic hypersomnia. |
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| Not yet recruiting | 3 | 24 | Europe | Sodium Oxybate, Oral solution, XYREM Sodium Oxybate | University Hospital of Montpellier, University Hospital of Montpellier | current idiopathic hypersomnia (ICSD-3) hypersomnie idiopathique, idiopathic hypersomnia hypersomnie idiopathique, Body processes [G] - Bones and nerves physological processes [G11] | | | | |