A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine
ClinicalTrials.gov processed this data on June 10, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified June 2024 by AbbVie
Sponsor
AbbVieInformation Provided by (Responsible Party)
AbbVieClinicaltrials.gov Identifier
NCT05216263Other Study ID Numbers: M22-418
First Submitted: January 19, 2022
First Posted: January 31, 2022
Last Update Posted: June 12, 2024
Last Verified: June 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 75 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine |
Study Start Date | March 22, 2022 |
Anticipated Primary Completion Date | December 27, 2024 |
Anticipated Study Completion Date | April 4, 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AEs) [Up to approximately 28 Weeks] An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
- Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary) [Baseline (Week 0) through 24 Weeks] Percentage of participants achieving at least 25% reduction from baseline in the frequency of monthly migraine days will be assessed.
- Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [Baseline (Week 0) through 24 Weeks] Percentage of participants achieving at least 30% reduction from baseline in the frequency of monthly migraine days will be assessed.
- Responder Status of at least 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [Baseline (Week 0) through 24 Weeks] Percentage of participants achieving at least 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
- Responder Status of at least 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [Baseline (Week 0) through 24 Weeks] Percentage of participants achieving at least 75% reduction from baseline in the frequency of monthly migraine days will be assessed.
- Responder Status of at least 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [Baseline (Week 0) through 24 Weeks] Percentage of participants achieving at least 100% reduction from baseline in the frequency of monthly migraine days will be assessed.
- Change From Baseline in Monthly Migraine Days [Baseline (Week 0) through 24 Weeks] Change from Baseline in monthly migraine days, defined by International Headache Society (IHS) Guidelines 2018 will be assessed.
- Change from Baseline in Monthly Headache Days, Moderate or Severe Headache Days, Cumulative Hours of Headache, Acute Treatment Medication Use Days, Headache Free Days, and Migraine Symptom-Free Days [Baseline (Week 0) through 24 Weeks] Change from baseline in monthly headache days, moderate or severe headache days, cumulative hours of headache, acute treatment medication use days, headache free days, and migraine symptom-free days, defined by IHS Guidelines 2018 will be assessed.
- Change from Baseline in Monthly days with Non-Headache Migraine Symptoms [Baseline (Week 0) through 24 Weeks] Change from baseline in monthly days with non-headache migraine symptoms such as photophobia, phonophobia, nausea and/or vomiting, dizziness, neck pain, tiredness, mood change, yawning, thirst, cravings, urinary frequency, cranial autonomic symptoms
- Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D) [Baseline (Week 0) through 24 Weeks] The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).
Eligibility Criteria
Ages Eligible for Study | 18 Years to 75 Years (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | AbbVie |
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Investigators |
More Information
Additional Information
Additional Relevant MeSH Terms
- Migraine Disorders
- Headache Disorders, Primary
- Headache Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases