* Long-term Eptinezumab in Patients With Chronic Cluster Headache

• Research type

  Research Study

• Full title

  Interventional, open-label, fixed-dose multiple administration study to evaluate long-term treatment with eptinezumab in patients with chronic cluster headache

• IRAS ID

  300297

• Contact name

  Peter Goadsby

• Contact email

  peter.goadsby@kcl.ac.uk

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2020-001968-28

• Clinicaltrials.gov Identifier

  NCT05064397

• Clinicaltrials.gov Identifier

  151358, IND Number

• Duration of Study in the UK

  1 years, 9 months, 5 days

• Research summary

  The purpose of this study is to evaluate how safe and how well-tolerated eptinezumab is, when used long-term by patients with chronic cluster headache.

  Eligible patients will receive four intravenous infusions of eptinezumab (400mg) at 12-week intervals.

  The study consists of a Screening Period (4 weeks), Treatment Period (48 weeks), and Safety Follow-Up Period (8 weeks). Total study duration for participants is expected to be around 56 weeks.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  21/FT/0084

• Date of REC Opinion

  23 Jul 2021

• REC opinion

  Further Information Favourable Opinion