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Be Part of Research - Trial Details - Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

Recruiting

Open to: ALL

Age: 18.0 - 75.0

Medical Conditions

Migraine Disorders


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.

Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.

All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).

There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2024 Sep 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Sequence 1;Sequence 2;Sequence 3;Sequence 4;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North Coast Medical Ltd - Newquay Health Centre /ID# 260019
    Newquay
    Cornwall
    TR7 1RU
  • The Adam Practice /ID# 258190
    Poole
    Dorset
    BH15 4JQ
  • Royal Primary Care Ashgate /ID# 258923
    Derbyshire
    S40 4AA
  • St Pancras Clinical Research /ID# 258183
    London
    EC2Y 8EA
  • Re:Cognition Health Birmingham /ID# 258186
    Birmingham
    B16 8LT
  • Re:Cognition Health - Guildford /ID# 258188
    Guildford
    GU2 7YD
  • The University of Nottingham Health Service /ID# 259380
    Nottingham
    NG7 2QW
  • Primary Care Sheffield /ID# 259448
    Sheffield
    S9 4EU
  • Re:Cognition Health Bristol /ID# 258187
    Bristol
    BS32 4SY
  • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384
    Glasgow
    Lanarkshire
    G51 4TF


The study is sponsored by AbbVie




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Read full details for Trial ID: NCT06241313
Last updated 11 July 2025

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