A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
ClinicalTrials.gov processed this data on May 30, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified May 2023 by AbbVie
Sponsor
AbbVieInformation Provided by (Responsible Party)
AbbVieClinicaltrials.gov Identifier
NCT04492020Other Study ID Numbers: 3110-304-002
First Submitted: July 27, 2020
First Posted: July 30, 2020
Results First Posted: May 31, 2023
Last Update Posted: May 31, 2023
Last Verified: May 2023
History of Changes
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Tracking Information | |
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First Submitted Date | July 27, 2020 |
First Posted Date | July 30, 2020 |
Results First Submitted Date | April 18, 2023 |
Results First Posted Date | May 31, 2023 |
Last Update Posted Date | May 31, 2023 |
Study Start Date | August 21, 2020 |
Actual Primary Completion Date | April 19, 2022 |
Current Primary Outcome Measures(submitted: May 30, 2023) |
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Change History | Complete list of historical versions of study NCT04492020 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants |
Official Title | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome |
Brief Summary | Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Crossover AssignmentMasking: DoublePrimary 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: Ubrogepant 100 mg For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours |
Study Groups/Cohorts | Experimental: Treatment Sequence AParticipants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event Intervention:
Experimental: Treatment Sequence BParticipants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event 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 | Completed |
Actual Enrollment(submitted: May 30, 2023) | 518 |
Actual Study Completion Date | April 19, 2022 |
Actual Primary Study Completion Date | April 19, 2022 |
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, 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, 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 | NCT04492020 |
Other Study ID Numbers | 3110-304-002 |
Has Data Monitoring Committee | No |
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 | May 2023 |