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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Niwa Family Clinic /ID# 232713 Coordinator of this site? Confirm its status | Chofu-shi | Japan | Unknown status |
| Fukuiken Saiseikai Hospital /ID# 232988 Coordinator of this site? Confirm its status | Fukui-shi | Japan | Unknown status |
| DOI Internal Medicine-Neurology Clinic /ID# 232722 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Hiroshima Neurology Clinic /ID# 232720 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Saitama Medical University Hospital /ID# 233017 Coordinator of this site? Confirm its status | Iruma-gun | Japan | Unknown status |
| Duplicate_Tokai University Hospital /ID# 233071 Coordinator of this site? Confirm its status | Isehara-shi | Japan | Unknown status |
| Atsuchi Neurosurgical Hospital /ID# 232907 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Tanaka Neurosurgical Clinic /ID# 232884 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Duplicate_Nagaseki Headache Clinic /ID# 232719 Coordinator of this site? Confirm its status | Kai-shi | Japan | Unknown status |
| Fujitsu Clinic /ID# 232717 Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Konan Medical Center /ID# 232922 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Umenotsuji Clinic /ID# 232675 Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| Tatsuoka Neurology Clinic /ID# 232912 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Takanoko Hospital /ID# 232723 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Mito Kyodo General Hospital /ID# 232990 Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Tominaga Hospital /ID# 232909 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saitama Neuropsychiatric Institute /Id# 232711 Coordinator of this site? Confirm its status | Saitama-shi | Japan | Unknown status |
| Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Duplicate_Tokyo Headache Clinic /ID# 232715 Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| Duplicate_Dokkyo Medical University Hospital /ID# 232995 Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Unknown status |
| Keio University Hospital /ID# 233030 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Japanese Red Cross Shizuoka Hospital /ID# 232992 Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Shinagawa Strings Clinic /ID# 232908 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.