A PHASE 3 STUDY TO EVALUATE ATOGEPANT FOR CHRONIC MIGRAINE

• Research type

  Research Study

• Full title

  A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ATOGEPANT FOR THE PREVENTION OF CHRONIC MIGRAINE (PROGRESS)

• IRAS ID

  270681

• Contact name

  Peter Goadsby

• Contact email

  peter.goadsby@kcl.ac.uk

• Sponsor organisation

  Allergan Ltd

• Eudract number

  2018-004337-32

• Clinicaltrials.gov Identifier

  NCT03855137

• Duration of Study in the UK

  1 years, 4 months, 30 days

• Research summary

  Atogepant is an investigational drug, which means it is not approved for sale in the UK. The purpose of this study is to look into the safety and tolerability of daily atogepant in the prevention of migraines.

  Approximately 750 participants will be randomised at approximately 140 sites worldwide. There will be approximately 30 participants in the UK.

  Participants can be male or female participants aged 18 to 80 years with at least a 1-year history of Chronic Migraine consistent with a diagnosis according to the The International Classification of Headache Disorders 3rd edition (ICHD-3), 2018.

  Participants will be assigned by chance to one of the following study groups:
  • Atogepant 30 mg twice daily
  • Atogepant 60 mg once daily
  • Placebo (a medically inactive substance that looks like study medication, but does not contain the study medication)

  There is an approximately 1 out of 3 chance that the participant will be assigned to receive placebo. The participant will take 4 tablets daily (2 tablets in the morning and 2 tablets in the evening). Neither the participant, nor the study doctor or study staff will know what study group the participant is in. However, this information can be made available should the study doctor decide it is medically necessary.

  There will be a total of 8 study visits over a period of approximately 20 weeks.
  The participant may need to attend additional unscheduled visits for safety or other reasons.

  If the participant receives active study drug and it is effective, they may experience a benefit. They may or may not receive any direct medical benefit from taking part in this study.
  Also, their taking part in the study may benefit others with the disease or condition as a result of the knowledge gained from this research.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  19/LO/1713

• Date of REC Opinion

  6 Jan 2020

• REC opinion

  Further Information Favourable Opinion