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NCT04437433CompletedPhase 3

A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Source: ClinicalTrials.gov · Last updated 22 Jul 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
186 (actual)
First submitted
16 Jun 2020
Start date
18 Jun 2020
Primary completion date
11 Jun 2024
Lead sponsor
AbbVie
Diseases
Migraine
NCT number
NCT04437433

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 186
  • From 18 Jun 2020 to the primary completion date, 11 Jun 2024
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Has \>= 15 headache days per month on average across the 3 months prior to Visit -1 in the investigator's judgment.
  • Usage of opioids or barbiturates \> 2 days/month, triptans or ergots \>= 10 days/month, or simple analgesics \>= 15 days/month in the 3 months prior to Visit -1 per investigator's judgment or during the baseline period.

Other illness

  • 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)
  • Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
    • De Novo EM Participants only:
  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.

Other

  • Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo EM Participants) or Visit 1 (3103-303-002 Completers).
  • Significant risk of self-harm based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator.
  • Difficulty distinguishing migraine headaches from tension-type or other headaches.
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018.
  • Has \>= 15 headache days in the 28-day baseline period per eDiary.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Niwa Family Clinic /ID# 232713
Coordinator of this site? Confirm its status
Chofu-shiJapanUnknown status
Fukuiken Saiseikai Hospital /ID# 232988
Coordinator of this site? Confirm its status
Fukui-shiJapanUnknown status
DOI Internal Medicine-Neurology Clinic /ID# 232722
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Hiroshima Neurology Clinic /ID# 232720
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Saitama Medical University Hospital /ID# 233017
Coordinator of this site? Confirm its status
Iruma-gunJapanUnknown status
Duplicate_Tokai University Hospital /ID# 233071
Coordinator of this site? Confirm its status
Isehara-shiJapanUnknown status
Atsuchi Neurosurgical Hospital /ID# 232907
Coordinator of this site? Confirm its status
KagoshimaJapanUnknown status
Tanaka Neurosurgical Clinic /ID# 232884
Coordinator of this site? Confirm its status
KagoshimaJapanUnknown status
Duplicate_Nagaseki Headache Clinic /ID# 232719
Coordinator of this site? Confirm its status
Kai-shiJapanUnknown status
Fujitsu Clinic /ID# 232717
Coordinator of this site? Confirm its status
Kawasaki-shiJapanUnknown status
Konan Medical Center /ID# 232922
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Umenotsuji Clinic /ID# 232675
Coordinator of this site? Confirm its status
KochiJapanUnknown status
Tatsuoka Neurology Clinic /ID# 232912
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Takanoko Hospital /ID# 232723
Coordinator of this site? Confirm its status
MatsuyamaJapanUnknown status
Mito Kyodo General Hospital /ID# 232990
Coordinator of this site? Confirm its status
MitoJapanUnknown status
Tominaga Hospital /ID# 232909
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Saitama Neuropsychiatric Institute /Id# 232711
Coordinator of this site? Confirm its status
Saitama-shiJapanUnknown status
Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677
Coordinator of this site? Confirm its status
SendaiJapanUnknown status
Duplicate_Tokyo Headache Clinic /ID# 232715
Coordinator of this site? Confirm its status
Shibuya-kuJapanUnknown status
Duplicate_Dokkyo Medical University Hospital /ID# 232995
Coordinator of this site? Confirm its status
Shimotsuga-gunJapanUnknown status
Keio University Hospital /ID# 233030
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Japanese Red Cross Shizuoka Hospital /ID# 232992
Coordinator of this site? Confirm its status
ShizuokaJapanUnknown status
Shinagawa Strings Clinic /ID# 232908
Coordinator of this site? Confirm its status
TokyoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.