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 October 31, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified October 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT05216263
Other Study ID Numbers: M22-418
First Submitted: January 19, 2022
First Posted: January 31, 2022
Last Update Posted: November 1, 2024
Last Verified: October 2024
History of Changes

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Tracking Information
First Submitted DateJanuary 19, 2022
First Posted DateJanuary 31, 2022
Last Update Posted DateNovember 1, 2024
Study Start DateMarch 22, 2022
Anticipated Primary Completion DateApril 4, 2025
Current Primary Outcome Measures
(submitted: October 31, 2024)
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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
  10. 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).
Change HistoryComplete list of historical versions of study NCT05216263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome MeasuresNot Provided
Current Other Outcome MeasuresNot Provided
Descriptive Information
Brief TitleStudy of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
Official TitleA 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
Brief SummaryMigraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored.

Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States.

All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
Condition
  • Chronic Migraine
Intervention

Drug: Atogepant

Oral Tablet

Study Groups/Cohorts

Experimental: Atogepant
Participants will receive atogepant once a day (QD) during the 24-week treatment period.

Intervention:
  • Drug: Atogepant
Publications *Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment
(submitted: October 31, 2024)
75
Anticipated Study Completion DateApril 4, 2025
Anticipated Primary Study Completion DateApril 4, 2025
Eligibility Criteria

Inclusion Criteria:

  • At least a 1-year history of chronic migraine (CM), with or without aura, consistent with a diagnosis according to International Classification of Headache Disorders 3rd edition (ICHD-3 2018) and with or without acute medication overuse as defined in the protocol.
  • Must be currently treated with BOTOX for CM: treated with >= 2 treatment cycles in the 8 months prior to Visit 2 (Day 1) with documentation of payer authorization or written attestation of self-pay to support continued use of BOTOX.
  • Must have 8 to 23 (inclusive) migraine days in the electronic diary [eDiary] screening/baseline period (eDiary data must have been collected for at least 20 days).

Exclusion Criteria:

  • Use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period.
  • Treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to Screening and throughout the study.
  • Concurrent use of any migraine prevention treatment other than BOTOX (required concomitant medication; or topiramate <=100mg daily) including use of oral gepants in the 4 weeks prior to screening nor during the screening/baseline period.
  • Current use or use within the 6 months (24 weeks) prior to Screening, of mAbs blocking the CGRP pathway.
  • Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to screening nor during the screening/baseline period.

Sex/GenderSexes Eligible for Study: All
Ages18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States
Administrative Information
NCT NumberNCT05216263
Other Study ID NumbersM22-418
Has Data Monitoring CommitteeYes
U.S FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No

Product Manufactured in and Exported from the U.S.: No

IPD Sharing StatementPlan to Share IPD: Yes
Responsible PartyAbbVie, AbbVie
Study SponsorAbbVie
CollaboratorsNot Provided
Investigators
PRS AccountAbbVie
Verification DateOctober 2024