Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Migraine Clinical Trial

— Release  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861427
• Other study ID #: M22-056
• Status: Recruiting
• Phase: Phase 3
• Start date: July 12, 2023
• Est. completion date: May 28, 2025

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: AbbVie GK Clinical Trial Registration Desk
• Phone: +81-3-4577-1111
• Email: abbvie_jpn_info_clingov[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: May 28, 2025
• Est. primary completion date: January 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet
• Placebo for Atogepant
Oral Tablet

Locations

Country	Name	City	State
Japan	Fukuiken Saiseikai Hospital /ID# 245662	Fukui-shi	Fukui
Japan	Tokai University Hachioji Hospital /ID# 248326	Hachioji-shi	Tokyo
Japan	DOI Internal Medicine-Neurology Clinic /ID# 245661	Hiroshima
Japan	Hiroshima City Hiroshima Citizens Hospital /ID# 246683	Hiroshima-shi	Hiroshima
Japan	Tokyo Dental College Ichikawa General Hospital /ID# 247436	Ichikawa-shi	Chiba
Japan	Saitama Medical University Hospital /ID# 245663	Iruma-gun	Saitama
Japan	Tokai University Hospital /ID# 245971	Isehara-shi	Kanagawa
Japan	Tanaka Neurosurgical clinic /ID# 245488	Kagoshima
Japan	Kijima Neurosurgery Clinic /ID# 245758	Kahoku-gun	Ishikawa
Japan	Nagaseki Headache Clinic /ID# 245485	Kai-shi	Yamanashi
Japan	Ikeda Neurosurgical Clinic /ID# 245881	Kasuga-shi	Fukuoka
Japan	Jinnouchi Neurosurgical Clinic /ID# 245510	Kasuga-shi	Fukuoka
Japan	Fujitsu Clinic /ID# 245811	Kawasaki-shi	Kanagawa
Japan	Konan Medical Center /ID# 245557	Kobe-shi	Hyogo
Japan	Atago Hospital /ID# 245818	Kochi-shi	Kochi
Japan	Umenotsuji Clinic /ID# 246103	Kochi-shi	Kochi
Japan	Saiseikai Kumamoto Hospital /Id# 253546	Kumamoto-shi	Kumamoto
Japan	Tatsuoka Neurology Clinic /ID# 245328	Kyoto
Japan	Takanoko Hospital /ID# 245658	Matsuyama-shi	Ehime
Japan	Kitasato University Kitasato Institute Hospital /ID# 246470	Minato-ku	Tokyo
Japan	Mito Kyodo General Hospital /ID# 245487	Mito-shi	Ibaraki
Japan	Nishinomiya Municipal Central Hospital /ID# 246571	Nishinomiya-shi	Hyogo
Japan	Yamaguchi Clinic /ID# 246370	Nishinomiya-shi	Hyogo
Japan	Kanazawa Neurosurgical Hospital /ID# 254210	Nonoichi-shi	Ishikawa
Japan	Ooba Clinic for Neurosurgery & Headache /ID# 246201	Oita-shi
Japan	Makabe Clinic /ID# 246621	Okayama-shi	Okayama
Japan	Okayama City General Medical Center /ID# 246007	Okayama-shi	Okayama
Japan	Chibune General Hospital /ID# 245973	Osaka-shi	Osaka
Japan	Gokeikai Osaka Kaisei Hospital /ID# 246623	Osaka-shi	Osaka
Japan	Tominaga Clinic /ID# 245812	Osaka-shi	Osaka
Japan	SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948	Ota-shi	Gunma
Japan	Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 245667	Sapporo-shi	Hokkaido
Japan	Nakamura Memorial Hospital /ID# 247379	Sapporo-shi	Hokkaido
Japan	Narikawa Neurological Clinic /ID# 254023	Sendai-shi	Miyagi
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664	Sendai-shi	Miyagi
Japan	Usuda Clinic Of Internal Medicine /ID# 246166	Setagaya-ku	Tokyo
Japan	Tokyo Headache Clinic /ID# 245486	Shibuya-ku	Tokyo
Japan	Dokkyo Medical University Hospital /ID# 246472	Shimotsuga-gun	Tochigi
Japan	Keio University Hospital /ID# 245660	Shinjuku-ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital /ID# 246204	Shizuoka-shi	Shizuoka
Japan	Suzuki Kei Yasuragi Clinic /ID# 253493	Tachikawa-shi	Tokyo
Japan	Kokubu Clinic /ID# 245810	Takamatsu
Japan	Tendo Brain Clinic /ID# 246205	Tendo-shi	Yamagata
Japan	Saino Clinic /ID# 245921	Tokorozawa-shi	Saitama
Japan	Shinagawa Strings Clinic /ID# 245665	Tokyo
Japan	Sakura neuro Clinic /ID# 248320	Toyama City	Toyama
Japan	Takase Internal Medicine Clinic /ID# 245532	Toyonaka-shi	Osaka
Japan	Tsukuba Neurosurgery/Headache Clinic /ID# 254665	Tsukuba-shi	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Monthly Migraine Days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to 12 Weeks
Secondary	Change From Baseline in Mean Monthly Headache Days	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to Week 12
Secondary	Change From Baseline in Mean Monthly Acute Medication Use Days	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.	Up to Week 12
Secondary	Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to Week 12
Secondary	Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score	MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.	Up to Week 12
Secondary	Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)	The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.	Up to Week 12
Secondary	Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D	The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.	Up to Week 12

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