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

NCT06241313
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,300
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Lead sponsor
AbbVie
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Start date
2024-03-25
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Number of sites
149
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Summary
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.
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Acronym
ATO ACUTE
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Short title
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
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Official title
Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-11-01
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First posted
2024-02-05
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Registry last updated
2026-06-24
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Primary completion date
2025-07-07
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Start date
2024-03-25
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Participants
1,300
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Participant count basis
Estimated
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Planned participants
1,300
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Protocol amendments
0
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Number of sites
149
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06241313
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ClinicalTrials.gov ID
NCT06241313
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.

  1. Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) at 2 Hours After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) will be assessed.

  2. Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.

  3. Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.

  4. Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.

  5. Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of participants with use of rescue medication within 24 hours after the DB dose for the first attack will be assessed.

  6. Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of participants with ability to function normally at 2 hours after the DB dose for the first attack will be assessed.

  7. Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.

  8. Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.

  9. Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Photophobia is defined as sensitivity to light.

  10. Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Phonophobia is defined as sensitivity to sound.

  11. Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.

  12. Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of participants with ability to function normally at 8 hours after the DB dose for the first attack will be assessed.

  13. Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.

  14. Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of participants with absence of nausea at 2 hours after the DB dose for the first attack.

  15. Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.

  16. Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack

    Timeframe: Approximately 16 Weeks

    Percentage of participants with ability to function normally at 1 hour after the DB dose for the first attack will be assessed.

  17. Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.

  18. Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.

  19. Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.

  20. Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.

  21. Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.

  22. Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks

    Timeframe: Approximately 16 Weeks

    Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
  • History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
  • Migraine onset before the age of 50.
  • History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

  • History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
  • Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.
Sources for eligibility
clinicaltrials.gov

  • Universitair Ziekenhuis Antwerpen /ID# 257582Edegem, Belgium
  • Universitair Ziekenhuis Brussel /ID# 257584Jette, Belgium
  • Saint-Nicolas, Belgium
  • Jessa Ziekenhuis /ID# 257578Hasselt, Belgium
  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 257585Bruges, Belgium
  • AZ Groeninge /ID# 257586Kortrijk, Belgium
  • H.-Hartziekenhuis Lier /ID# 257577Lier, Belgium
  • CHR de la Citadelle /ID# 257587Liège, Belgium
  • The first affiliated hospital of bengbu medical college /ID# 258758Bengbu, China
  • Beijing Friendship Hospital /ID# 258830Beijing, China
  • Xuanwu Hospital Capital Medical University /ID# 258510Beijing, China
  • Peking University Third Hospital /ID# 259573Beijing, China
  • Chinese PLA General Hospital /ID# 257540Beijing, China
  • Peking University First Hospital /ID# 258672Xicheng District, China
  • Fujian Medical University Union Hospital /ID# 259575Fuzhou, China
  • The First Affiliated Hospital of Xiamen University /ID# 259576Xiamen, China
  • Lanzhou University Second Hospital /ID# 259667Lanzhou, China
  • Guangzhou First People's Hospital /ID# 258656Guangzhou, China
  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638Guangzhou, China
  • The University Of Hong Kong - Shenzhen Hospital /ID# 258462Shenzhen, China
  • The Affiliated Hospital of Guizhou Medical University /ID# 259536Guiyang, China
  • Hainan General Hospital /ID# 259548Haikou, China
  • Hebei General Hospital /ID# 258583Shijiazhuang, China
  • Zhengzhou People's Hospital /ID# 258670Zhengzhou, China
  • The Second Xiangya Hospital Of Central South University /ID# 260623Changsha, China

And 124 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506029-12-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)