Clinical trial NCT05861427: Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
Official title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Episodic Migraine
Atogepant
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.

Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan.

Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* At least a 1-year history of migraine (with or without aura).
* Less than 50 years of age at the time of migraine onset.
* History of 4 to 14 migraine days per month in the 3 months prior to screening.
* 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary.

Exclusion Criteria:

* Difficulty with distinguishing migraine headaches from tension-type or other headaches.
* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Primary outcomes:
measure: Change From Baseline in Mean Monthly Migraine Days
timeFrame: Up to 12 Weeks
measure: Number of Participants Experiencing With Adverse Events (AEs)
timeFrame: Up to approximately 28 Weeks
Secondary outcomes:
measure: Change From Baseline in Mean Monthly Headache Days
timeFrame: Up to Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days
timeFrame: Up to Week 12
measure: Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days
timeFrame: Up to Week 12
measure: Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
timeFrame: Up to Week 12
measure: Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)
timeFrame: Up to Week 12
measure: Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Ichikawa-shi
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital /ID# 247436
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Takanoko Hospital /ID# 245658
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukuiken Saiseikai Hospital /ID# 245662
state: Fukui
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgical Clinic /ID# 245510
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgical Clinic /ID# 245881
state: Fukuoka
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital /ID# 246683
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Nakamura Memorial Hospital /ID# 247379
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 245557
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Nishinomiya Municipal Central Hospital /ID# 246571
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Yamaguchi Clinic /ID# 246370
state: Hyogo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital /ID# 245487
state: Ibaraki
city: Tsukuba-shi
country: Japan
facility: Tsukuba Neurosurgery/Headache Clinic /ID# 254665
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Kijima Neurosurgery Clinic /ID# 245758
state: Ishikawa
city: Nonoichi-shi
country: Japan
facility: Kanazawa Neurosurgical Hospital /ID# 254210
state: Ishikawa
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 245971
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Fujitsu Clinic /ID# 245811
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Atago Hospital /ID# 245818
state: Kochi
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 246103
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital /Id# 253546
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Narikawa Neurological Clinic /ID# 254023
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664
state: Miyagi
city: Okayama-shi
country: Japan
facility: Makabe Clinic /ID# 246621
state: Okayama
city: Okayama-shi
country: Japan
facility: Okayama City General Medical Center /ID# 246007
state: Okayama
city: Osaka-shi
country: Japan
facility: Gokeikai Osaka Kaisei Hospital /ID# 246623
state: Osaka
city: Osaka-shi
country: Japan
facility: Chibune General Hospital /ID# 245973
state: Osaka
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 245812
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Takase Internal Medicine Clinic /ID# 245532
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 245663
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: Saino Clinic /ID# 245921
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital /ID# 246204
state: Shizuoka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 246472
state: Tochigi
city: Hachioji-shi
country: Japan
facility: Tokai University Hachioji Hospital /ID# 248326
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 246470
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Usuda Clinic Of Internal Medicine /ID# 246166
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic /ID# 245486
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 245660
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Suzuki Kei Yasuragi Clinic /ID# 253493
state: Tokyo
city: Toyama City
country: Japan
facility: Sakura neuro Clinic /ID# 248320
state: Toyama
city: Tendo-shi
country: Japan
facility: Tendo Brain Clinic /ID# 246205
state: Yamagata
city: Kai
country: Japan
facility: Nagaseki Headache Clinic /ID# 245485
state: Yamanashi
city: Hiroshima
country: Japan
facility: DOI Internal Medicine-Neurology Clinic /ID# 245661
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgical Clinic /ID# 245488
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic /ID# 245328
city: Oita-shi
country: Japan
facility: Ooba Clinic for Neurosurgery & Headache /ID# 246201
city: Takamatsu
country: Japan
facility: Kokubu Clinic /ID# 245810
city: Tokyo
country: Japan
facility: Shinagawa Strings Clinic /ID# 245665
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: