Clinical trial NCT04437433: A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Migraine
Episodic Migraine
Keywords: Chronic Migraine
Episodic Migraine
Atogepant
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
timeFrame: Across the 52-week treatment period
Secondary outcomes:
measure: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
timeFrame: Across the 52-week treatment period
measure: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
timeFrame: Across the 52-week treatment period
measure: Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
timeFrame: Across the 52-week treatment period
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
timeFrame: Across the 52-week treatment period
Other outcomes:
Locations:
city: Matsuyama-shi
country: Japan
facility: Takanoko Hospital /ID# 232723
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukuiken Saiseikai Hospital /ID# 232988
state: Fukui
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 232922
state: Hyogo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital /ID# 232990
state: Ibaraki
city: Kagoshima-shi
country: Japan
facility: Atsuchi Neurosurgical Hospital /ID# 232907
state: Kagoshima
city: Isehara-shi
country: Japan
facility: Duplicate_Tokai University Hospital /ID# 233071
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Fujitsu Clinic /ID# 232717
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 232675
state: Kochi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677
state: Miyagi
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 233017
state: Saitama
city: Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute /Id# 232711
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital /ID# 232992
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Duplicate_Dokkyo Medical University Hospital /ID# 232995
state: Tochigi
city: Chofu-shi
country: Japan
facility: Niwa Family Clinic /ID# 232713
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic /ID# 232715
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 233030
state: Tokyo
city: Kai-shi
country: Japan
facility: Nagaseki Headache Clinic /ID# 232719
state: Yamanashi
city: Hiroshima
country: Japan
facility: DOI Internal Medicine-Neurology Clinic /ID# 232722
city: Hiroshima
country: Japan
facility: Hiroshima Neurology Clinic /ID# 232720
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgical Clinic /ID# 232884
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic /ID# 232912
city: Osaka
country: Japan
facility: Tominaga Hospital /ID# 232909
city: Tokyo
country: Japan
facility: Shinagawa Strings Clinic /ID# 232908
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: