Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Chronic Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216263
• Other study ID #: M22-418
• Status: Recruiting
• Phase: Phase 3
• Start date: March 22, 2022
• Est. completion date: April 4, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 4, 2025
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet

Locations

Country	Name	City	State
United States	Albany Medical College /ID# 242757	Albany	New York
United States	Dent Neurosciences Research Center, Inc. /ID# 241776	Amherst	New York
United States	Michigan Headache & Neurological Institute (MHNI) /ID# 241784	Ann Arbor	Michigan
United States	Neurology Offices of South Florida, PLLC /ID# 242693	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center /ID# 241800	Boston	Massachusetts
United States	Minneapolis Clinic of Neurology - Burnsville /ID# 241994	Burnsville	Minnesota
United States	Hope Clinical Research /ID# 241772	Canoga Park	California
United States	Profound Research LLC /ID# 244084	Carlsbad	California
United States	Chattanooga Medical Research /ID# 253295	Chattanooga	Tennessee
United States	Ochsner Clinic Foundation /ID# 241803	Covington	Louisiana
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	Neuro Pain Medical Center /ID# 241992	Fresno	California
United States	Headache Wellness Center /ID# 241791	Greensboro	North Carolina
United States	Neurology and Neurodiagnostics of Alabama /ID# 242538	Hoover	Alabama
United States	Coastal Clinical Research Specialists /ID# 247992	Jacksonville Beach	Florida
United States	Frontier Clinical Research - Kingwood /ID# 242928	Kingwood	West Virginia
United States	Arkansas Clinical Research /ID# 241789	Little Rock	Arkansas
United States	University of Miami /ID# 252230	Miami	Florida
United States	West Virginia Univ School Med /ID# 252869	Morgantown	West Virginia
United States	Nashville Neuroscience Group /ID# 243592	Nashville	Tennessee
United States	Kansas Institute of Research /ID# 241796	Overland Park	Kansas
United States	Jefferson Hospital for Neuroscience /ID# 243712	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute /ID# 241812	Phoenix	Arizona
United States	Neurological Research Institute /ID# 242688	Santa Monica	California
United States	First Physicians Group - Waldemere /ID# 242861	Sarasota	Florida
United States	Puget Sound Neurology /ID# 241787	Tacoma	Washington
United States	Preferred Primary Care Physicians - Jacob Murphy /ID# 241798	Uniontown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 28 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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.	Baseline (Week 0) through 24 Weeks
Primary	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	Baseline (Week 0) through 24 Weeks
Primary	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).	Baseline (Week 0) through 24 Weeks

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