Jazz 15-006: Efficacy and Safety Study in Cataplexy and Narcolepsy

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy

• IRAS ID

  211806

• Contact name

  Kirstie Anderson

• Contact email

  kirstie.anderson@nuth.nhs.uk

• Sponsor organisation

  Jazz Pharmaceuticals Inc.

• Eudract number

  2016-000426-20

• Duration of Study in the UK

  2 years, 0 months, 20 days

• Research summary

  This is a phase 3 study to evaluate the efficacy of JZP-258 in the treatment of cataplexy in subjects with narcolepsy.
  The study has 5 periods with different timescales:
  - Screening Period - up to 30 days
  - Open-Label Optimised Treatment and Titration Period - 12 weeks
  - Stable-dose Period - 2 weeks
  - Double-Blind Randomised-Withdrawal Period - 2 weeks
  - Safety Follow-up Period - 2 weeks

  In order to determine how subjects will take the drug JZP-258, subjects will be placed in one of the following four groups depending on the medicine that was taken to treat narcolepsy with cataplexy before study entry.
  - Group 1: Xyrem taken alone at study entry
  - Group 2: Xyrem and an additional anti-cataplectic medicine taken at study entry
  - Group 3: Non-Xyrem anti-cataplectic taken at study entry
  - Group 4: No anti-cataplectic medicine taken at study entry

  Approximately 185 people will be enrolled in the study in multiple countries. The study will take place over approximately 22 months with subject participation lasting up to approximately 18 weeks. Subjects who complete the screening Period and the Open-Label Optimised Titration Phase will be given a stable dose of JZP-258, adjusted and decided by the study doctor. This will be followed by the Double-Blind Randomised Period where subjects will receive either JZP-258 or placebo.
  Subjects will stop taking study drug at the End of Double-Blind Randomised-Withdrawal Period. Subject may withdraw their participation in the study at any time. This will not affect care and/or benefits received due to their condition.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  16/SC/0436

• Date of REC Opinion

  24 Aug 2016

• REC opinion

  Favourable Opinion