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      • This website is for UK Healthcare Professionals only

      This promotional material is intended for UK healthcare professionals (HCPs) experienced in the diagnosis and management of migraine only. Prescribing Information and adverse event reporting information can be found below.
      dekstop updated

      UK-AQP-240034. DOP: March 2025.

      ADVANCE study design 

      In the ADVANCE study, AQUIPTA® achieved a reduction in monthly migraine/headache days vs placebo across 12 weeks1,2

      The ADVANCE study
      ADVANCE was a 12-week, multicentre, double-blind, parallel‑group, randomised, placebo‑controlled phase III trial to examine the efficacy and safety of AQUIPTA® for the prevention of migraine in patients with 4–14 migraine days/month.1,2

      a-p2-aw1

      Adapted from Ailani J et al. 20212

      Atogepant 30 mg once-daily is not included here as this is not a licensed dose.

      The data presented here is from the modified intent-to-treat (mITT) population, as per the pre-specified analysis in the studies. It therefore may differ slightly from the data in the AQUIPTA® Summary of Product Characteristics, which uses the off-treatment hypothetical estimand (OTHE) population at the request of the European Medicines Agency. Both populations consisted of all randomised participants who received at least one dose of study treatment, had an evaluable baseline period and at least one evaluable post‑baseline 4-week period (Weeks 1–4, 5–8 and 9–12) of diary data, but the latter was:2

      • during the double-blinded treatment period for the mITT population
      • during the combined double-blind treatment period and follow-up period, regardless of whether on or off study treatment, for the OTHE population

      *Eligible participants were randomised in a 1:1:1:1 ratio to receive atogepant 10 mg, 30 mg or 60 mg once-daily or placebo. Randomisation was stratified according to participants' previous exposure to an oral migraine‑prevention treatment using an automated interactive web‑response system.2

      See endpoints and exclusion criteria

      CGRP: calcitonin gene-related peptide; mITT: modified intent-to-treat; OTHE: off-treatment hypothetical estimand.

      References:

      1. AQUIPTA® Summary of Product Characteristics.
      2. Ailani J, Lipton R B et al. Atogepant for the preventive treatment of migraine. N Engl J Med 2021;385(8):695–706 (+ suppl)

      References:

      1. AQUIPTA® Summary of Product Characteristics.
      2. Ailani J, Lipton R B et al. Atogepant for the preventive treatment of migraine. N Engl J Med 2021;385(8):695–706 (+ suppl)

       

      Please refer to the AQUIPTA® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use. The AQUIPTA® Summary of Product Characteristics can be found here.

      AQUIPTA® PRESCRIBING INFORMATION

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      UK-AQP-250090 | Date of preparation: March 2025.

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk

      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

      ADVANCE study design

      ADVANCE: a 12-week, multicentre, double‑blind, parallel‑group, randomised, placebo‑controlled phase III trial to examine the efficacy and safety of AQUIPTA®▼ (atogepant) for the prevention of migraine in patients with 4–14 migraine days/month.1,2

      PRIMARY ENDPOINT2

      Change from baseline in the mean number of migraine days per month across 12 weeks of treatment

      SECONDARY ENDPOINT2

      > Change from baseline in the mean number of headache days per month across 12 weeks of treatment

      > Change from baseline in the mean number of days of acute medication use across 12 weeks of treatment

      > ≥50% reduction from baseline in the 3‑month average of migraine days per month

      > Change from baseline in the score on the Migraine‑Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function‑Restrictive (RFR)
      at Week 12

      > Change from baseline in the mean monthly score of Activity Impairment in Migraine - Diary (AIM-D) performance of daily activities (PDA) and physical impairment (PI) domains across 12 weeks of treatment

      > Change from baseline in Headache Impact Test-6 (HIT-6) total score at Week 12

      INCLUSION CRITERIA2

      > Aged 18–80 years

      > 4–14 migraine days per month in the 3 months before Visit 1 and during the 4-week screening period

      > At least a 1-year history of migraine with or without aura, diagnosed as specified in the International Classification of Headache Disorders, 3rd edition (ICHD-3)

      > Migraine onset before 50 years of age

      EXCLUSION CRITERIA2

      > Patients with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening

      > A history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine

      > Current diagnosis of chronic migraine, new daily persistent headache, trigeminal autonomic cephalalgia or painful cranial neuropathy

      > History of inadequate response to >4 oral medications prescribed for the preventative treatment of migraine (≥2 having different mechanisms of action)

      > Clinically significant haematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal or neurologic disease

      > Women who are pregnant, planning to become pregnant or currently breastfeeding

      ADVANCE study design

      ADVANCE: a 12-week, multicentre, double‑blind, parallel‑group, randomised, placebo‑controlled phase III trial to examine the efficacy and safety of AQUIPTA®▼ (atogepant) for the prevention of migraine in patients with 4–14 migraine days/month.1,2

      PRIMARY ENDPOINT2

      Change from baseline in the mean number of migraine days per month across 12 weeks of treatment

      SECONDARY ENDPOINT2

      > Change from baseline in the mean number of headache days per month across 12 weeks of treatment

      > Change from baseline in the mean number of days of acute medication use across 12 weeks of treatment

      > ≥50% reduction from baseline in the 3‑month average of migraine days per month

      > Change from baseline in the score on the Migraine‑Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function‑Restrictive (RFR) at Week 12

      > Change from baseline in the mean monthly score of Activity Impairment in Migraine - Diary (AIM-D) performance of daily activities (PDA) and physical impairment (PI) domains across 12 weeks of treatment

      > Change from baseline in Headache Impact Test-6 (HIT-6) total score at Week 12

      INCLUSION CRITERIA2

      > Aged 18–80 years

      > 4–14 migraine days per month in the 3 months before Visit 1 and during the 4-week screening period

      > At least a 1-year history of migraine with or without aura, diagnosed as specified in the International Classification of Headache Disorders, 3rd edition (ICHD-3)

      > Migraine onset before 50 years of age

      EXCLUSION CRITERIA2

      > Patients with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening

      > A history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine

      > Current diagnosis of chronic migraine, new daily persistent headache, trigeminal autonomic cephalalgia or painful cranial neuropathy

      > History of inadequate response to >4 oral medications prescribed for the preventative treatment of migraine (≥2 having different mechanisms of action)

      > Clinically significant haematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal or neurologic disease

      > Women who are pregnant, planning to become pregnant or currently breastfeeding

      overlay 1 table

      BMI: body mass index

      Prescribing information and adverse event reporting

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      References: 1. AQUIPTA® Summary of Product Characteristics.
      2. Ailani J, Lipton R B et al. Atogepant for the preventive treatment of migraine. N Engl J Med 2021;385(8):695–706 (+ suppl)

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.