Clinical trial NCT05216263: Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Migraine
Keywords: Chronic Migraine
Migraine
Atogepant
OnabotulinumtoxinA
BOTOX
QULIPTA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 28 Weeks
measure: Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary)
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Responder Status of at least 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Responder Status of at least 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Responder Status of at least 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Change From Baseline in Monthly Migraine Days
timeFrame: Baseline (Week 0) through 24 Weeks
measure: 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
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Change from Baseline in Monthly days with Non-Headache Migraine Symptoms
timeFrame: Baseline (Week 0) through 24 Weeks
measure: Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D)
timeFrame: Baseline (Week 0) through 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Neurology and Neurodiagnostics of Alabama /ID# 242538
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Clinical Research /ID# 241789
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research /ID# 241772
state: California
city: Carlsbad
country: United States
facility: Profound Research LLC /ID# 244084
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 241992
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute /ID# 242688
state: California
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida, PLLC /ID# 242693
state: Florida
city: Jacksonville Beach
country: United States
facility: Coastal Clinical Research Specialists /ID# 247992
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 252230
state: Florida
city: Sarasota
country: United States
facility: First Physicians Group - Waldemere /ID# 242861
state: Florida
city: Overland Park
country: United States
facility: Kansas Institute of Research /ID# 241796
state: Kansas
city: Covington
country: United States
facility: Ochsner Clinic Foundation /ID# 241803
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 241800
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 241784
state: Michigan
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology - Burnsville /ID# 241994
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College /ID# 242757
state: New York
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst /ID# 241776
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 241791
state: North Carolina
city: Philadelphia
country: United States
facility: Jefferson Hospital for Neuroscience /ID# 243712
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 253295
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group /ID# 243592
state: Tennessee
city: Dallas
country: United States
facility: Texas Neurology /ID# 241795
state: Texas
city: Falls Church
country: United States
facility: Inova Health System /ID# 252242
state: Virginia
city: Falls Church
country: United States
facility: Integrated Neurology Services - Falls Church /ID# 244747
state: Virginia
city: Tacoma
country: United States
facility: Puget Sound Neurology /ID# 241787
state: Washington
city: Kingwood
country: United States
facility: Frontier Clinical Research - Kingwood /ID# 242928
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia Univ School Med /ID# 252869
state: West Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: