A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Ch… (NCT04437433) | Clinical Trial Compass
CompletedPhase 3
A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
Japan186 participantsStarted 2020-06-18
Plain-language summary
This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
3101-303-002 Completers:
* Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.
De Novo EM Participants:
* Age of the participant at the time of migraine onset \< 50 years.
* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
* History of 4 to 14 migraine days per month on average in the 3 months prior to Visit -1 in the investigator's judgment.
* 4 to 14 migraine days in the 28-day baseline period per eDiary.
* Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.
Exclusion Criteria:
* Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment.
* Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo EM Participants) or Visit 1 (3103-303-002 Completers).
* Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit -1 (De Novo EM Participants) or Visit 1 (for all participants)
* Significant …
What they're measuring
1
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)
Timeframe: From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)