Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
- Registration Number
- NCT05216263
- Lead Sponsor
- AbbVie
- Brief Summary
Migraine 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 Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant Atogepant Participants will receive atogepant once a day (QD) during the 24-week treatment period.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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).
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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Michigan Headache & Neurological Institute (MHNI) /ID# 241784
🇺🇸Ann Arbor, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 241994
🇺🇸Burnsville, Minnesota, United States
Albany Medical College /ID# 242757
🇺🇸Albany, New York, United States
Dent Neurosciences Research Center, Inc. /ID# 241776
🇺🇸Amherst, New York, United States
Neurology and Neurodiagnostics of Alabama /ID# 242538
🇺🇸Hoover, Alabama, United States
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
🇺🇸Phoenix, Arizona, United States
Arkansas Clinical Research /ID# 241789
🇺🇸Little Rock, Arkansas, United States
Hope Clinical Research /ID# 241772
🇺🇸Canoga Park, California, United States
Profound Research LLC /ID# 244084
🇺🇸Carlsbad, California, United States
Neuro Pain Medical Center /ID# 241992
🇺🇸Fresno, California, United States
Neurological Research Institute /ID# 242688
🇺🇸Santa Monica, California, United States
Neurology Offices of South Florida, PLLC /ID# 242693
🇺🇸Boca Raton, Florida, United States
Coastal Clinical Research Specialists /ID# 247992
🇺🇸Jacksonville Beach, Florida, United States
University of Miami /ID# 252230
🇺🇸Miami, Florida, United States
First Physicians Group - Waldemere /ID# 242861
🇺🇸Sarasota, Florida, United States
Kansas Institute of Research /ID# 241796
🇺🇸Overland Park, Kansas, United States
Ochsner Clinic Foundation /ID# 241803
🇺🇸Covington, Louisiana, United States
Beth Israel Deaconess Medical Center /ID# 241800
🇺🇸Boston, Massachusetts, United States
Headache Wellness Center /ID# 241791
🇺🇸Greensboro, North Carolina, United States
Jefferson Hospital for Neuroscience /ID# 243712
🇺🇸Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
🇺🇸Uniontown, Pennsylvania, United States
Chattanooga Medical Research /ID# 253295
🇺🇸Chattanooga, Tennessee, United States
Nashville Neuroscience Group /ID# 243592
🇺🇸Nashville, Tennessee, United States
Texas Neurology /ID# 241795
🇺🇸Dallas, Texas, United States
Inova Health System /ID# 252242
🇺🇸Falls Church, Virginia, United States
Integrated Neurology Services - Falls Church /ID# 244747
🇺🇸Falls Church, Virginia, United States
Puget Sound Neurology /ID# 241787
🇺🇸Tacoma, Washington, United States
Frontier Clinical Research - Kingwood /ID# 242928
🇺🇸Kingwood, West Virginia, United States
West Virginia Univ School Med /ID# 252869
🇺🇸Morgantown, West Virginia, United States