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
ClinicalTrials.gov processed this data on October 31, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified October 2024 by AbbVie
Sponsor
AbbVieInformation Provided by (Responsible Party)
AbbVieClinicaltrials.gov Identifier
NCT05216263Other Study ID Numbers: M22-418
First Submitted: January 19, 2022
First Posted: January 31, 2022
Last Update Posted: November 1, 2024
Last Verified: October 2024
History of Changes
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Tracking Information | |
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First Submitted Date | January 19, 2022 |
First Posted Date | January 31, 2022 |
Last Update Posted Date | November 1, 2024 |
Study Start Date | March 22, 2022 |
Anticipated Primary Completion Date | April 4, 2025 |
Current Primary Outcome Measures(submitted: October 31, 2024) |
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Change History | Complete list of historical versions of study NCT05216263 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures | Not Provided |
Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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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/AInterventional Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Drug: Atogepant Oral Tablet |
Study Groups/Cohorts | Experimental: AtogepantParticipants will receive atogepant once a day (QD) during the 24-week treatment period. Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Active, not recruiting |
Actual Enrollment(submitted: October 31, 2024) | 75 |
Anticipated Study Completion Date | April 4, 2025 |
Anticipated Primary Study Completion Date | April 4, 2025 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: All |
Ages | 18 Years to 75 Years (Adult, Older Adult) |
Accepts Healthy Volunteers | No |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States |
Administrative Information | |
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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 |
Responsible Party | AbbVie, AbbVie |
Study Sponsor | AbbVie |
Collaborators | Not Provided |
Investigators | |
PRS Account | AbbVie |
Verification Date | October 2024 |