Back to resultsStudy of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atogepant
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic Migraine, Migraine, Atogepant, OnabotulinumtoxinA, BOTOX, QULIPTA
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 to support continued use of BOTOX.
- Must have 8 to 23 (inclusive) migraine days in the eDiary screening/baseline period (electronic diary [eDiary] data must have been collected for at least 20 days).
Exclusion Criteria:
- Use of opioid-containing products for more than 4 days 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 injection of anesthetics/steroids within 4 weeks prior to Screening.
- Concurrent use of any migraine prevention treatment other than BOTOX (including use of oral gepants) in the 4 weeks prior to Visit 1 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 Visit 1 nor during the screening/baseline period.
Sites / Locations
- Neurology and Neurodiagnostics of Alabama /ID# 242538Recruiting
- Barrow Neurological Institute /ID# 241812Recruiting
- Arkansas Clinical Research /ID# 241789
- Hope Clinical Research /ID# 241772Recruiting
- North County Neurology Associates /ID# 244084Recruiting
- Neuro Pain Medical Center /ID# 241992Recruiting
- Neurological Research Institute /ID# 242688Recruiting
- Neurology Offices of South Florida, PLLC /ID# 242693Recruiting
- Coastal Clinical Research Specialists /ID# 247992Recruiting
- University of Miami /ID# 252230Recruiting
- First Physicians Group - Waldemere /ID# 242861Recruiting
- Kansas Institute of Research /ID# 241796Recruiting
- Ochsner Clinic Foundation /ID# 241803Recruiting
- Beth Israel Deaconess Medical Center /ID# 241800Recruiting
- Michigan Headache & Neurological Institute (MHNI) /ID# 241784Recruiting
- Minneapolis Clinic of Neurology - Burnsville /ID# 241994Recruiting
- Albany Medical College /ID# 242757Recruiting
- Dent Neurosciences Research Center, Inc. /ID# 241776Recruiting
- Headache Wellness Center /ID# 241791Recruiting
- Jefferson Hospital for Neuroscience /ID# 243712Recruiting
- Preferred Primary Care Physicians - Jacob Murphy /ID# 241798Recruiting
- Chattanooga Medical Research /ID# 253295Recruiting
- Nashville Neuroscience Group /ID# 243592Recruiting
- Texas Neurology /ID# 241795Recruiting
- Integrated Neurology Services - Falls Church /ID# 244747Recruiting
- Puget Sound Neurology /ID# 241787Recruiting
- Frontier Clinical Research - Kingwood /ID# 242928Recruiting
- West Virginia Univ School Med /ID# 252869Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atogepant
Arm Description
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs)
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)
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
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
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
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
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
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
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
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)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05216263
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 125 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
Chronic Migraine, Migraine, Atogepant, OnabotulinumtoxinA, BOTOX, QULIPTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atogepant
Arm Type
Experimental
Arm Description
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
QULIPTA
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 28 Weeks
Title
Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary)
Description
Percentage of participants achieving at least 25% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
Description
Percentage of participants achieving at least 30% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Responder Status of at least 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
Description
Percentage of participants achieving at least 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Responder Status of at least 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
Description
Percentage of participants achieving at least 75% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Responder Status of at least 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
Description
Percentage of participants achieving at least 100% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Change From Baseline in Monthly Migraine Days
Description
Change from Baseline in monthly migraine days, defined by International Headache Society (IHS) Guidelines 2018 will be assessed.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
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
Description
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.
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Change from Baseline in Monthly days with Non-Headache Migraine Symptoms
Description
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
Time Frame
Baseline (Week 0) through 24 Weeks
Title
Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D)
Description
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).
Time Frame
Baseline (Week 0) through 24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Neurology and Neurodiagnostics of Alabama /ID# 242538
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244-5700
Country
United States
Individual Site Status
Recruiting
Facility Name
Barrow Neurological Institute /ID# 241812
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4407
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Clinical Research /ID# 241789
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Completed
Facility Name
Hope Clinical Research /ID# 241772
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303-1855
Country
United States
Individual Site Status
Recruiting
Facility Name
North County Neurology Associates /ID# 244084
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011-4213
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro Pain Medical Center /ID# 241992
City
Fresno
State/Province
California
ZIP/Postal Code
93710-5473
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurological Research Institute /ID# 242688
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Offices of South Florida, PLLC /ID# 242693
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428-2231
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Clinical Research Specialists /ID# 247992
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250-1694
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami /ID# 252230
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
First Physicians Group - Waldemere /ID# 242861
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239-2943
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Institute of Research /ID# 241796
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1363
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Clinic Foundation /ID# 241803
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-8107
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center /ID# 241800
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Headache & Neurological Institute (MHNI) /ID# 241784
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Individual Site Status
Recruiting
Facility Name
Minneapolis Clinic of Neurology - Burnsville /ID# 241994
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337-6732
Country
United States
Individual Site Status
Recruiting
Facility Name
Albany Medical College /ID# 242757
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
650-815-9807
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 241776
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Wellness Center /ID# 241791
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Jefferson Hospital for Neuroscience /ID# 243712
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5191
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Name
Chattanooga Medical Research /ID# 253295
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Nashville Neuroscience Group /ID# 243592
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-2646
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Neurology /ID# 241795
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrated Neurology Services - Falls Church /ID# 244747
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043-2367
Country
United States
Individual Site Status
Recruiting
Facility Name
Puget Sound Neurology /ID# 241787
City
Tacoma
State/Province
Washington
ZIP/Postal Code
25328
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research - Kingwood /ID# 242928
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537-9797
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia Univ School Med /ID# 252869
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
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