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

• ClinicalTrials.gov Identifier: NCT05216263
• Recruitment Status: Recruiting
• First Posted: January 31, 2022
• Last Update Posted: April 30, 2024
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: January 19, 2022
• First Posted Date: January 31, 2022
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: March 22, 2022
• Estimated Primary Completion Date: December 27, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2023)

• Number of Participants With Adverse Events (AEs) [ Time Frame: 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.
• Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary) [ Time Frame: 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.
• Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [ Time Frame: 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 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [ Time Frame: 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 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [ Time Frame: 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 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary [ Time Frame: 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 Migraine Days [ Time Frame: Baseline (Week 0) through 24 Weeks ]
  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 [ Time Frame: 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.
• Change from Baseline in Monthly days with Non-Headache Migraine Symptoms [ Time Frame: 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
• Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D) [ Time Frame: 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).

Original Primary Outcome Measures (submitted: January 19, 2022)

• Number of Participants With Adverse Events (AEs) [ Time Frame: 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.
• Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Defined by International Headache Society (IHS) Guidelines 2018 Collected via Daily Electronic Diary (eDiary) [ Time Frame: 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.
• Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Defined by IHS Guidelines 2018 Collected via eDiary [ Time Frame: 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 50% Reduction in the Frequency of Monthly Migraine Days Defined by IHS Guidelines 2018 Collected via eDiary [ Time Frame: 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 75% Reduction in the Frequency of Monthly Migraine Days Defined by IHS Guidelines 2018 Collected via eDiary [ Time Frame: 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 100% Reduction in the Frequency of Monthly Migraine Days Defined by IHS Guidelines 2018 Collected via eDiary [ Time Frame: 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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: January 19, 2022)

Change From Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through 24 Weeks ]

Change from Baseline in mean monthly migraine days, defined by IHS Guidelines 2018 will be assessed.

Descriptive Information

• 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

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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Migraine

Intervention

Drug: Atogepant

Oral Tablet

Other Name: QULIPTA

Study Arms

Experimental: Atogepant

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

Intervention: Drug: Atogepant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 29, 2024): 75
• Original Estimated Enrollment (submitted: January 19, 2022): 125
• Estimated Study Completion Date: April 4, 2025
• Estimated Primary Completion Date: December 27, 2024 (Final data collection date for primary outcome measure)

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/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05216263
• Other Study ID Numbers: M22-418
• Has Data Monitoring Committee: Yes

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 Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Allergan
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: April 2024