Migraine
Conditions
Keywords
Migraine, Atogepant, ECLIPSE, Qulipta, Aquipta
Brief 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.
Interventions
DRUGAtogepant
Oral Tablet
Oral Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack | Approximately 16 Weeks | Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Approximately 16 Weeks | Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) will be assessed. |
| Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack | 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. |
| Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack | Approximately 16 Weeks | Photophobia is defined as sensitivity to light. |
| Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack | Approximately 16 Weeks | Phonophobia is defined as sensitivity to sound. |
| Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack | Approximately 16 Weeks | Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain. |
| Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack | 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. |
| Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack | 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. |
| Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack | Approximately 16 Weeks | Percentage of participants with absence of nausea at 2 hours after the DB dose for the first attack. |
| Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack | 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. |
| Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack | 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. |
| Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks | Approximately 16 Weeks | Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain. |
| Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks | 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. |
| Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks | 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. |
| Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks | 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. |
| Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks | 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. |
| Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks | 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. |
Countries
Belgium, China, Czechia, Germany, Hungary, Italy, Japan, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed