A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
- Registration Number
- NCT04437433
- Lead Sponsor
- AbbVie
- Brief 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 or episodic migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
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.
- 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 Episodic Migraine 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.
- 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.
- Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
De Novo EM Participants only:
- Difficulty distinguishing migraine headaches from tension-type or other headaches.
- Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.
- 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 per month on average across the 3 months prior to Visit 1 in the investigator's judgment.
- Has >= 15 headache days in the 28-day baseline period per eDiary.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant 60 mg Atogepant 60 mg Taken once daily
- Primary Outcome Measures
Name Time Method Percentage of Participants with at Least 1 Treatment Emergent Adverse Event Across the 52-week treatment period
- Secondary Outcome Measures
Name Time Method Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales Across the 52-week treatment period A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator Across the 52-week treatment period Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator Across the 52-week treatment period Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator Across the 52-week treatment period
Trial Locations
- Locations (24)
Takanoko Hospital /ID# 232723
🇯🇵Matsuyama-shi, Ehime, Japan
Mito Kyodo General Hospital /ID# 232990
🇯🇵Mito-shi, Ibaraki, Japan
Saitama Neuropsychiatric Institute /Id# 232711
🇯🇵Saitama-shi, Saitama, Japan
Shinagawa Strings Clinic /ID# 232908
🇯🇵Tokyo, Japan
Keio University Hospital /ID# 233030
🇯🇵Shinjuku-ku, Tokyo, Japan
Atsuchi Neurosurgical Hospital /ID# 232907
🇯🇵Kagoshima-shi, Kagoshima, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677
🇯🇵Sendai-shi, Miyagi, Japan
Japanese Red Cross Shizuoka Hospital /ID# 232992
🇯🇵Shizuoka-shi, Shizuoka, Japan
DOI Internal Medicine-Neurology Clinic /ID# 232722
🇯🇵Hiroshima, Japan
Tatsuoka Neurology Clinic /ID# 232912
🇯🇵Kyoto, Japan
Fukuiken Saiseikai Hospital /ID# 232988
🇯🇵Fukui-shi, Fukui, Japan
Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710
🇯🇵Sapporo-shi, Hokkaido, Japan
Konan Medical Center /ID# 232922
🇯🇵Kobe-shi, Hyogo, Japan
Fujitsu Clinic /ID# 232717
🇯🇵Kawasaki-shi, Kanagawa, Japan
Umenotsuji Clinic /ID# 232675
🇯🇵Kochi-shi, Kochi, Japan
Duplicate_Tokai University Hospital /ID# 233071
🇯🇵Isehara-shi, Kanagawa, Japan
Saitama Medical University Hospital /ID# 233017
🇯🇵Iruma-gun, Saitama, Japan
Duplicate_Dokkyo Medical University Hospital /ID# 232995
🇯🇵Shimotsuga-gun, Tochigi, Japan
Nagaseki Headache Clinic /ID# 232719
🇯🇵Kai-shi, Yamanashi, Japan
Tokyo Headache Clinic /ID# 232715
🇯🇵Shibuya-ku, Tokyo, Japan
Niwa Family Clinic /ID# 232713
🇯🇵Chofu-shi, Tokyo, Japan
Hiroshima Neurology Clinic /ID# 232720
🇯🇵Hiroshima, Japan
Tanaka Neurosurgical Clinic /ID# 232884
🇯🇵Kagoshima, Japan
Tominaga Hospital /ID# 232909
🇯🇵Osaka, Japan