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Adverse events when ubrogepant or atogepant are taken during pregnancy (EMPRESS, NCT05158894)

Study title/design: Observational study to assess adverse events when adult female participants are treated with ubrogepant or atogepant during pregnancy (EMPRESS, NCT05158894) Trial NCT05827887. Recruiting. Estimated primary completion September 2034, estimated study completion September 2034 Aim To evaluate foetal, maternal, and infant outcomes through 12 months of age among women exposed to ubrogepant or atogepant …

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Phase 3 study of oral atogepant tablets to assess adverse events and change in disease activity to prevent migraine in participants aged 12 to 17 Years (NCT06810505)

Study title/design: Phase 3 study of oral atogepant tablets to assess adverse events and change in disease activity to prevent migraine in participants aged 12 to 17 Years (NCT06810505) Trial NCT06810505. Recruiting. Estimated primary completion: March 2031, estimated study completion March 2031 Aim To evaluate the safety and efficacy of atogepant for the preventive treatment …

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Comparative effectiveness of migraine preventive medications (APT, NCT06972056)

Study title/design: Comparative effectiveness of migraine preventive medications (APT, NCT06972056) Trial NCT06972056. Recruiting. Primary completion 1 March 2029, study completion 1 December 2029 Aim To compare the effectiveness of topiramate and propranolol for migraine prevention. Study design Participants randomised to atogepant up to 60 mg, topiramate up to 100 mg or propranolol up to 160 …

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An observational study to assess ubrogepant tablets and atogepant tablets to treat migraine in adult participants (COBRA, NCT05827887)

Study title/design: An observational study to assess ubrogepant tablets and atogepant tablets to treat migraine in adult participants (COBRA, NCT05827887) Trial NCT05827887. Recruiting. Estimated primary completion September 2025, estimated study completion September 2025 Aim To evaluate the effectiveness of ubrogepant and atogepant in treating adults with migraine. Study design Participants will receive ubrogepant or atogepant tablets as …

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Phase 3 study of oral atogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine (ATO MM, NCT06806293)

Study title/design: Phase 3 study of oral atogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine (ATO MM, NCT06806293) Trial NCT06806293. Recruiting. Estimated primary completion February 2027, estimated study completion July 2027 Aim To evaluate the efficacy, safety, and tolerability of atogepant for the preventive treatment of menstrual migraine. Study …

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Study of oral atogepant tablets to assess safety and efficacy in adult participants with migraine (ATO ACUTE/ECLIPSE, NCT06241313)

Study title/design: Study of oral atogepant tablets to assess safety and efficacy in adult participants with migraine (ATO ACUTE/ECLIPSE, NCT06241313) Trial NCT06241313. Recruiting. Primary completion July 2025, study completion November 2026 Aim To evaluate the safety and efficacy of oral atogepant for the acute treatment of migraine in adults. Study design Double-blind phase in which patients are …

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Phase 3 comparative study of oral atogepant versus oral topiramate to assess adverse events in adults with migraine (ATO-TOPIRAMATE/TEMPLE, NCT05748483)

Study title/design: Phase 3 comparative study of oral atogepant versus oral topiramate to assess adverse events in adult participants with migraine (ATO-TOPIRAMATE/TEMPLE, NCT05748483) Trial NCT05748483. Active, not recruiting. Primary completion April 2025, study completion May 2026 Aim To evaluate the tolerability, safety, and efficacy of atogepant versus topiramate in participants requiring preventive treatment of migraine. Study design Period 1: …

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Phase 4 study to assess adverse events when ubrogepant tablets are used with atogepant tablets to treat adults with migraine (TANDEM, NCT05264129)

Study title/design: Phase 4 study to assess adverse events when ubrogepant tablets are used in combination with atogepant tablets to treat adult participants with migraine (TANDEM, NCT05264129) Trial NCT05264129 (Completed) Aim Multicentre, open-label study to evaluate the safety, tolerability, and efficacy of concomitant ubrogepant for acute treatment of migraine in patients taking atogepant for the …

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A Phase 3, multicenter, 12-week, double blind, placebo-controlled study to evaluate the safety and efficacy of atogepant for the preventive treatment of episodic migraine in pediatric subjects aged 6-17 years of age (NCT05711394)

Study title/design: A Phase 3, multicenter, 12-week, double blind, placebo-controlled study to evaluate the safety and efficacy of atogepant for the preventive treatment of episodic migraine in pediatric subjects aged 6-17 years of age (NCT05711394) Trial NCT05711394 (Recruiting) Aim To assess the adverse events and changes in disease activity of oral atogepant tablets in paediatric …

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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 (NCT05216263)

Study title/design: 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 (NCT05216263) Trial NCT05216263 Completed Aim To assess adverse events and change in disease activity when oral atogepant is added to onabotulinumtoxinA in adult participants with …

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A prospective observational diary study to evaluate the real-world effectiveness of acute treatment of migraine with ubrogepant when used in combination with atogepant for prevention (COURAGE II) (NCT057653986)

Study title/design: A prospective observational diary study to evaluate the real-world effectiveness of acute treatment of migraine with ubrogepant when used in combination with atogepant for prevention (COURAGE II, NCT057653986) Trial NCT05653986 Aim To assess change in disease activity when ubrogepant tablets are combined with atogepant tablets to treat migraine in adult participants. Study design …

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A long-term safety and tolerability extension study evaluating atogepant for the prevention of chronic or episodic migraine (NCT04686136)

Study title/design: A long-term safety and tolerability extension study evaluating atogepant for the prevention of chronic or episodic migraine (NCT04686136) Trial NCT0486136 Aim To evaluate the long-term safety and tolerability of atogepant 60 mg daily for the prevention of migraine in patients with chronic or episodic migraine Study design Phase 3, multicentre, open-label 52-week extension …

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Atogepant for migraine prophylaxis in patients who failed previous oral prophylactic treatments (ELEVATE) (NCT04740827)

Study title/design: Atogepant for migraine prophylaxis in patients who failed previous oral prophylactic treatments (ELEVATE) (NCT04740827) Trial NCT04740827 Aim To evaluate the safety, tolerability and efficacy of atogepant in episodic migraine in participants who previously failed 2 to 4 classes of oral prophylactic treatments. Study design Phase 3, multicentre, double-blind, placebo-controlled, parallel-group study of atogepant …

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A Phase 3, multicentre, open-label 40-week extension study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (NCT03939312)

Study title/design: A Phase 3, multicentre, open-label 40-week extension study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (NCT03939312) Trial NCT03939312 Aim To evaluate the safety and tolerability of atogepant 60 mg once daily for the prevention of migraine in patients with episodic …

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A Phase 3, multicentre, randomised, double-blind, placebo-group study to evaluate the efficacy, safety and tolerability of atogepant for the prevention of chronic migraine (PROGRESS) (NCT03855137)

Study title/design: A Phase 3, multicentre, randomised, double-blind, placebo-group study to evaluate the efficacy, safety and tolerability of atogepant for the prevention of chronic migraine (PROGRESS)  (NCT03855137) Trial NCT03855137. Completed Aim To evaluate the efficacy, safety and tolerability of atogepant in patients with chronic migraine Study design Study of patients aged 18-80 years randomised to …

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A Phase 3, multicentre, randomised, open-label study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (NCT03700320)

Study title/design: A Phase 3, multicentre, randomised, open-label study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (NCT03700320) Trial NCT03700320 Aim To evaluate the safety and tolerability of atogepant 60 mg once daily for the prevention of migraine in patients with episodic migraine …

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A Phase 3, multicentre, randomised double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (ADVANCE) (NCT03777059)

Study title/design: A Phase 3, multicentre, randomised double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine (ADVANCE, NCT03777059) Trial NCT03777059. Completed Aim To evaluate the safety and tolerability of atogepant 10 mg, 30 mg and 60 mg once a day …

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A phase 2/3, multicentre, randomised, double-blind, placebo controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple dosing regimens of oral AGN-241689 in episodic migraine prevention

Atogepant (AGN-241689) Study title/design: A phase 2b/3, multicentre, randomised, double-blind, placebo controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple dosing regimens of oral AGN-241689 in episodic migraine prevention Trial NCT02848326 Aim To evaluate the safety and tolerability of AGN-241689 (atogepant) 10 mg once daily (QD), 30 mg QD, 30 mg twice daily …

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