Use of extended release sodium oxybate for treatment of narcolepsy.

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

• IRAS ID

  208393

• Contact name

  Adrian Williams

• Contact email

  Adrian.Williams@gstt.nhs.uk

• Sponsor organisation

  Flamel Technologies Headquarters

• Eudract number

  2016-000359-29

• Clinicaltrials.gov Identifier

  NCT02720744

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  This is a double-blind, randomised, placebo-controlled, 2-arm multicentre clinical study to assess the efficacy and safety of a once nightly formulation of sodium oxybate (FT218) for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy.Two populations of narcoleptic participants will be monitored in a single parallel group design: 1) narcolepsy with both EDS and episodic muscle weakness (NT1), and 2) narcolepsy with EDS but with no muscle weakness (NT2). Patients will undergo a 3 week screening period followed by daily dosing of 4.5 g sodium oxybate for 1 week, 6.0 g sodium oxybate for 2 weeks, 7.5 g sodium oxybate for 5 weeks, and 9.0 g sodium oxybate for 5 weeks. Medication will be given orally at bedtime. Patients will undergo a 1 week follow up period.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/1509

• Date of REC Opinion

  25 Oct 2016

• REC opinion

  Further Information Favourable Opinion