Open Label extension study to evaluate Atogepant for Chronic Migraine

• Research type

  Research Study

• Full title

  A PHASE 3, MULTICENTER, OPEN-LABEL 52-WEEK EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL ATOGEPANT FOR THE PREVENTION OF MIGRAINE IN PARTICIPANTS WITH CHRONIC OR EPISODIC MIGRAINE

• IRAS ID

  293973

• Contact name

  Nikki Amaratunge

• Contact email

  Amaratunge_Nikki@Allergan.com

• Sponsor organisation

  Allergan Limited

• Eudract number

  2020-002470-27

• Clinicaltrials.gov Identifier

  NCT04686136

• Duration of Study in the UK

  2 years, 7 months, 1 days

• Research summary

  This is a multicenter, open-label, 52-week, long-term safety extension study conducted in all eligible participants who complete either lead-in Study 3101-303-002 (Phase 3 CM study) or Study 3101-304-002 (Phase 3 EM study). All participants will be treated with atogepant 60 mg once daily.
  
  The study will consist of a 52-week open-label treatment period, and a safety follow-up period of 4 weeks.

• REC name

  London - Central Research Ethics Committee

• REC reference

  21/LO/0502

• Date of REC Opinion

  27 Aug 2021

• REC opinion

  Further Information Favourable Opinion