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Efficacy and Safety of JZP-258 in Narcolepsy with Cataplexy (Randomized-Withdrawal)
2016-000426-20Phase 3Completed
- Sponsor
- Jazz Pharmaceuticals plc
- Start
- Jul 2016
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in narcolepsy type 1 (NT1) and Excessive Daytime Sleepiness (EDS) comparing JZP-258 continuation arm with Placebo randomized-withdrawal arm (2 arms). Primary endpoint: Change in weekly number of cataplexy attacks. Started Jul 2016; status: completed.
02
Drugs
sodium oxybate + calcium oxybate + potassium oxybate + magnesium oxybate
03
Conditions
narcolepsy type 1 (NT1)Excessive Daytime Sleepiness (EDS)
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