M21-201 Atogepant for the Treatment of Pediatric Subjects with Episodic Migraine

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age

• IRAS ID

  1007166

• Contact name

  Elma Stephen

• Contact email

  elma.stephen@nhs.scot

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2022-001085-35

• ISRCTN Number

  N.A

• Clinicaltrials.gov Identifier

  NCT05711394

• Research summary

  A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adult patients with migraine but there are limited approved treatments available for young patients. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in young patients between the ages of 6 and 17.
  Atogepant is a medicine currently approved to treat adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied in young patients between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in patients with a history of episodic migraine with an open-label pharmacokinetic (PK; how a medication moves into, through, and out of the body and blood) substudy.
  Eligible patients will be randomized into 6 different groups. Patients between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Patients between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in patients between the ages of 6 and 11 will be determined after the PK substudy is complete. At the end of Week 12, patients will either undergo a follow-up visit Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  23/EM/0089

• Date of REC Opinion

  29 Aug 2023

• REC opinion

  Further Information Favourable Opinion