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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| ClinicalTrials.gov Identifier: NCT05216263 |
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Recruitment Status :
Recruiting
First Posted : January 31, 2022
Last Update Posted : March 12, 2024
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
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- No Results Posted
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- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Migraine | Drug: Atogepant | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 22, 2022 |
| Estimated Primary Completion Date : | December 27, 2024 |
| Estimated Study Completion Date : | December 27, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Migraine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atogepant
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
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Drug: Atogepant
Oral Tablet
Other Name: QULIPTA |
Primary Outcome Measures :
- 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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216263
Contacts
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
Locations
Show 29 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05216263 |
| Other Study ID Numbers: |
M22-418 |
| First Posted: | January 31, 2022 Key Record Dates |
| Last Update Posted: | March 12, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (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 Statistical Analysis Plan (SAP) 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/ |
| 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 |
Keywords provided by AbbVie:
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Chronic Migraine Migraine Atogepant |
OnabotulinumtoxinA BOTOX QULIPTA |
Additional relevant MeSH terms:
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Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |