A Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

5 Mar 2025 → ongoing

Decision date (initial)

2025-02-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Others, Safety

The primary objective is to evaluate the efficacy of atogepant taken consecutively for 7 days compared to placebo for the preventive treatment of MM.

Secondary objectives 1

1. The secondary objective of the study is to evaluate the safety and tolerability of atogepant treatment in subjects with MM.

Conditions and MedDRA coding

Menstrual Migraine

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult individuals, at least 18 years old, who by history and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
2. History of migraine (with or without aura) according to the ICHD-3 for ≥ 12 months prior to Visit 1/Screening.
3. Migraine onset before age 50 years.
4. By history at Visit 1/Screening, subject meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day –2 to Day +3 relative to menses onset) in the opinion of the investigator.
5. Subject records 3 PMPs in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day.

Exclusion criteria 7

1. History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
2. An average of 15 or more headache days per month recorded in the eDiary during the screening period.
3. History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
4. Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3.
5. Subject required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
6. Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
7. Subject has a condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.

Secondary endpoints 7

1. CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period
2. 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period
3. CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period
4. CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period
5. 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period
6. No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period
7. CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 10

Locations

7 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 65 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications