Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855137
• Other study ID #: 3101-303-002
• Secondary ID: 2018-004337-32
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2019
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

Other known NCT identifiers

• NCT04961671

Recruitment information / eligibility

• Status: Completed
• Enrollment: 778
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018

• Age of the participant at the time of migraine onset < 50 years

• Confirmation of headache/migraine headache day frequency as follows:

• History of, on average, = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND

• >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND

• >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary

• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria:

• Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine

• Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy

• History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine

• Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant 30 mg
Tablets containing 30 mg atogepant
• Atogepant 60 mg
Tablets containing 60 mg atogepant
• Placebo
30 mg/60 mg tablets containing atogepant-matching placebo

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital /ID# 236859	Parkville	Victoria
Australia	Royal North Shore Hospital /ID# 237008	St Leonards	New South Wales
Canada	CHAMP Clinic /ID# 236252	Calgary	Alberta
Canada	Clinique des cephalees de Montreal /ID# 236266	Montreal	Quebec
Canada	Montreal Neurological Institut /ID# 236329	Montreal	Quebec
Canada	Ottawa Headache Centre Research Inc /ID# 236432	Ottawa	Ontario
Canada	Vancouver Island Health Authority /ID# 238053	Victoria	British Columbia
China	Beijing Friendship Hospital /ID# 237264	Beijing
China	Chinese PLA General Hospital /ID# 238237	Beijing	Beijing
China	Peking University Third Hospital /ID# 238150	Beijing	Beijing
China	The Second Hospital of Jilin University /ID# 236520	Changchun	Jilin
China	Guangzhou First People's Hospital /ID# 236510	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260	Hangzhou	Zhejiang
China	Jiangsu Province Hospital /ID# 237846	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847	Shanghai	Shanghai
China	The Second Hospital of Soochow University /ID# 234296	Suzhou
China	The Second Hospital of Shanxi Medical University /ID# 236529	Taiyuan	Shanxi
China	Tianjin Huanhu Hospital (THH) /ID# 236524	Tianjin
China	Hubei General Hospital /ID# 236486	Wuhan	Hebei
China	Tongji Hospital Tongji Medical College of HUST /ID# 237835	Wuhan
China	The First Affiliated Hospital of Zhengzhou University /ID# 237025	Zhengzhou	Henan
Czechia	NEUROHK s.r.o. /ID# 236290	Hradec Kralove
Czechia	BRAIN-SOULTHERAPY s.r.o. /ID# 236380	Kladno
Czechia	CCR Ostrava, s.r.o. /ID# 234291	Ostrava
Czechia	FORBELI s.r.o. /ID# 236427	Prague
Czechia	CLINTRIAL s.r.o. /ID# 237793	Prague 10
Czechia	CCR Czech a.s /ID# 236249	Prague 4
Czechia	CCR Prague s.r.o. /ID# 236250	Praha
Czechia	Thomayerova nemocnice /ID# 237175	Praha
Czechia	NeuroMed Zlin s.r.o. /ID# 236416	Zlin
Denmark	Rigshospitalet Glostrup /ID# 236411	Glostrup	Hovedstaden
France	Hôpital Pierre Wertheimer /ID# 236969	Bron
France	CHU Gabriel Montpied /ID# 237323	Clermont Ferrand
France	AP-HM - Hopital de la Timone /ID# 236285	Marseille CEDEX 05	Bouches-du-Rhone
France	CH Annecy Genevois Site Annecy /ID# 236385	PRINGY cedex	Haute-Savoie
Germany	Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256	Berlin
Germany	Praxis Dr. Gendolla /ID# 236311	Essen
Germany	Universitaetsklinikum Essen /ID# 237209	Essen
Germany	CTC North GmbH & Co. KG /ID# 236328	Hamburg
Germany	Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723	Kassel
Germany	Schmerzklinik Kiel /ID# 236444	Kiel
Germany	LMU Klinikum Campus Grosshadern /ID# 236293	München
Italy	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492	Bari
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 237598	Florence
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291	Milan
Italy	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361	Napoli
Italy	Universita di Pavia /ID# 236363	Pavia
Italy	IRCCS San Raffaele Pisana /ID# 236552	Rome
Japan	Niwa Family Clinic /ID# 234552	Chofu-shi	Tokyo
Japan	Fukuiken Saiseikai Hospital /ID# 236794	Fukui-shi	Fukui
Japan	DOI Internal Medicine-Neurology Clinic /ID# 234562	Hiroshima
Japan	Hiroshima Neurology Clinic /ID# 234563	Hiroshima
Japan	Saitama Medical University Hospital /ID# 237019	Iruma-gun	Saitama
Japan	Tokai University Hospital /ID# 237595	Isehara-shi	Kanagawa
Japan	Tanaka Neurosurgical clinic /ID# 234760	Kagoshima
Japan	Atsuchi Neurosurgical Hospital /ID# 234779	Kagoshima-shi	Kagoshima
Japan	Nagaseki Headache Clinic /ID# 234561	Kai-shi	Yamanashi
Japan	Fujitsu Clinic /ID# 237443	Kawasaki-shi	Kanagawa
Japan	Konan Medical Center /ID# 236230	Kobe-shi	Hyogo
Japan	Umenotsuji Clinic /ID# 234495	Kochi-shi	Kochi
Japan	Tatsuoka Neurology Clinic /ID# 234782	Kyoto
Japan	Takanoko Hospital /ID# 234564	Matsuyama-shi	Ehime
Japan	Tominaga Hospital /ID# 234781	Osaka
Japan	Saitama Neuropsychiatric Institute /Id# 234550	Saitama-shi	Saitama
Japan	Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549	Sapporo-shi	Hokkaido
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496	Sendai-shi	Miyagi
Japan	Tokyo Headache Clinic /ID# 234555	Shibuya-ku	Tokyo
Japan	Dokkyo Medical University Hospital /ID# 236810	Shimotsuga-gun	Tochigi
Japan	Keio University Hospital /ID# 237210	Shinjuku-ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital /ID# 234372	Shizuoka-shi	Shizuoka
Japan	Shinagawa Strings Clinic /ID# 234780	Tokyo
Korea, Republic of	Pusan National University Hospital /ID# 237120	Busan
Korea, Republic of	Dongtan Sacred Heart Hospital /ID# 238097	Hwaseong	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 237754	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Nowon Eulji Medical Center, Eulji University /ID# 236306	Seoul
Korea, Republic of	Samsung Medical Center /ID# 237785	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 237786	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 237839	Seoul	Seoul Teugbyeolsi
Poland	NZOZ Vitamed /ID# 237041	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Gdynia /ID# 237077	Gdynia	Pomorskie
Poland	Silmedic Sp. z o.o. /ID# 237343	Katowice	Slaskie
Poland	Centrum Leczenia Padaczki i Migreny /ID# 236386	Krakow	Malopolskie
Poland	Specjalistyczne Gabinety Sp. z o.o. /ID# 236348	Krakow	Malopolskie
Poland	Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289	Lublin	Lubelskie
Poland	Solumed Centrum Medyczne /ID# 236452	Poznan	Wielkopolskie
Poland	EuroMedis sp. z o.o. /ID# 236417	Szczecin	Zachodniopomorskie
Russian Federation	Kazan State Medical University /ID# 236298	Kazan	Tatarstan, Respublika
Russian Federation	State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354	Kazan	Tatarstan, Respublika
Russian Federation	Central Clinical Hospital RZHD Medicine /ID# 237024	Moscow
Russian Federation	Clinics Chaika /ID# 236394	Moscow
Russian Federation	University Headache Clinic /ID# 236371	Moscow
Spain	Hospital Universitario Vall d'Hebron /ID# 236467	Barcelona
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645	Pamplona	Navarra
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 237623	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen del Rocio /ID# 237106	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 237400	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 237087	Valencia
Spain	Hospital Clinico Universitario de Valladolid /ID# 234406	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 237373	Zaragoza
Sweden	Stortorgets Neurologmottagning /ID# 236454	Helsingborg
Taiwan	Kuang-Tien General Hospital /ID# 236309	Taichung City
Taiwan	Chi-Mei Medical Center /ID# 236724	Tainan
Taiwan	Tainan Sin Lau Hospital /ID# 236358	Tainan City
Taiwan	Taipei Veterans General Hosp /ID# 237236	Taipei City
Taiwan	Tri-Service General Hospital /ID# 237657	Taipei City
United Kingdom	Walton Centre /ID# 236468	Liverpool
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 236301	London
United States	Abington Neurological Associates - Abington /ID# 236258	Abington	Pennsylvania
United States	Albany Medical Center Rheumatology /ID# 236540	Albany	New York
United States	Albuquerque Clinical Trials, Inc /ID# 236853	Albuquerque	New Mexico
United States	Dent Neurosciences Research Center, Inc. /ID# 237040	Amherst	New York
United States	NeuroTrials Research Inc. /ID# 237364	Atlanta	Georgia
United States	Northwest Clinical Research Center /ID# 237581	Bellevue	Washington
United States	Beth Israel Deaconess Medical Center /ID# 237540	Boston	Massachusetts
United States	Alpine Clinical Research Center /ID# 234346	Boulder	Colorado
United States	DiscoveResearch, Inc /ID# 236274	Bryan	Texas
United States	WR-ClinSearch /ID# 238288	Chattanooga	Tennessee
United States	Stetson-University of Cincinnati /ID# 236453	Cincinnati	Ohio
United States	Ochsner Clinic Foundation /ID# 236543	Covington	Louisiana
United States	Texas Neurology /ID# 236359	Dallas	Texas
United States	University of Texas Southwestern Medical Center /ID# 236941	Dallas	Texas
United States	California Headache and Balance Center /ID# 236246	Fresno	California
United States	Headache Wellness Center /ID# 236431	Greensboro	North Carolina
United States	Josephson-Wallack-Munshower Neurology - NE /ID# 238234	Indianapolis	Indiana
United States	Nevada Headache Institute /ID# 236420	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center /ID# 237444	Lebanon	New Hampshire
United States	Baptist Health Center for Clinical Research /ID# 237361	Little Rock	Arkansas
United States	Wr-Pri Llc /Id# 236008	Los Alamitos	California
United States	MedStar Georgetown Neurology /ID# 236324	McLean	Virginia
United States	Clinical Neuroscience Solutions - Memphis /ID# 237478	Memphis	Tennessee
United States	Clinical Research Institute, Inc /ID# 238299	Minneapolis	Minnesota
United States	BTC of New Bedford /ID# 236384	New Bedford	Massachusetts
United States	Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692	Newport Beach	California
United States	Barrow Neuro Institute /ID# 236776	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc. /ID# 236439	Pittsburgh	Pennsylvania
United States	Collective Medical Research /ID# 236400	Prairie Village	Kansas
United States	Raleigh Neurology Associates /ID# 237141	Raleigh	North Carolina
United States	Headache Neurology Research Institute /ID# 236464	Ridgeland	Mississippi
United States	Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161	Saint Petersburg	Florida
United States	Highland Clinical Research /ID# 237816	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395	Salt Lake City	Utah
United States	J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297	Salt Lake City	Utah
United States	Schuster Medical Research Institute /ID# 236447	Sherman Oaks	California
United States	Puget Sound Neurology /ID# 236321	Tacoma	Washington
United States	Accel Research Sites - Tampa Clinical Research Unit /ID# 237485	Tampa	Florida
United States	Sentara Neurology Specialists - Virginia Beach /ID# 234349	Virginia Beach	Virginia
United States	George Washington University Medical Faculty Associates /ID# 238011	Washington	District of Columbia
United States	Premiere Research Institute - Palm Beach /ID# 238192	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population	Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Primary	Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population	Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population	Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population	Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population	Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.	Baseline to Week 12
Secondary	Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population	Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.	Baseline 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 at Week 12 in Off-Treatment Hypothetical Estimand Population	The 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 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	At Week 12
Secondary	Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population	The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population	The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.	Baseline to Week 12
Secondary	Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population	HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.	At Week 12

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