M21-307: Phase 3 Study of BOTOX for the Prevention of Migraine in subjects with Episodic Migraine

• Research type

  Research Study

• Full title

  Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects with Episodic Migraine

• IRAS ID

  1005398

• Contact name

  Alice Butler

• Contact email

  ukregulatory@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2021-001979-16

• Clinicaltrials.gov Identifier

  NCT05028569

• Research summary

  Migraine is a neurological disease characterised by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorised according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.
  BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world. Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  22/NW/0147

• Date of REC Opinion

  20 Jun 2022

• REC opinion

  Further Information Favourable Opinion