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

Phase 3

Completed

Conditions: Episodic Migraine
Chronic Migraine

Interventions: Drug: Atogepant 60 mg

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 (CM) or episodic migraine (EM).

Detailed Description: The study recruited the following 2 cohorts:

3101-303-002 CM Completers: Japanese participants who completed lead-in Study 3101 303-002 (PROGRESS; NCT03855137), a Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study of atogepant for the prevention of CM. All 3101 303-002 CM Completers rolled over at Visit 7 (the end of the double-blind treatment period) of the lead-in study, which functioned as Visit 1 for this study, Study 3101-306-002.

De Novo EM Participants: Japanese participants with EM who were newly recruited for this study at selected sites. Participation began with a 4-week Screening/Baseline period starting at Visit -1, and those who completed the 4-week Screening/Baseline period and met all entry criteria were enrolled into the 52-week open-label treatment period at Visit 1.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 186

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 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atogepant 60 mg Chronic Migraine	Atogepant 60 mg	Participants with chronic migraine (CM) who completed lead-in Study 3101-303-002 (NCT03855137) received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.
Atogepant 60 mg Episodic Migraine	Atogepant 60 mg	Participants with episodic migraine (EM) who were newly recruited and met all study entry criteria received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)	From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator	From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)	Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis.
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator	Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52	12-lead ECGs were performed at select study visits.
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator	From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)	Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], and weight.
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period	From first dose of study drug until the last dose of study drug (up to 52 weeks)	The C-SSRS is 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 Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period	Up to 4 weeks following the last dose of study drug	The C-SSRS is 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).

Trial Locations

Locations (24): Takanoko Hospital /ID# 232723
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Matsuyama-shi, Ehime, Japan
Fukuiken Saiseikai Hospital /ID# 232988
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Fukui-shi, Fukui, Japan
Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710
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Sapporo-shi, Hokkaido, Japan
Konan Medical Center /ID# 232922
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Kobe-shi, Hyogo, Japan
Mito Kyodo General Hospital /ID# 232990
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Mito-shi, Ibaraki, Japan
Atsuchi Neurosurgical Hospital /ID# 232907
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Kagoshima-shi, Kagoshima, Japan
Duplicate_Tokai University Hospital /ID# 233071
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Isehara-shi, Kanagawa, Japan
Fujitsu Clinic /ID# 232717
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Kawasaki-shi, Kanagawa, Japan
Umenotsuji Clinic /ID# 232675
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Kochi-shi, Kochi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677
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Sendai-shi, Miyagi, Japan
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Takanoko Hospital /ID# 232723
🇯🇵Matsuyama-shi, Ehime, Japan