Trial Review

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03855137




Registration number
NCT03855137
Ethics application status
Date submitted
25/02/2019
Date registered
26/02/2019
Date last updated
14/02/2023

Titles & IDs
Public title
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Scientific 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)
Secondary ID [1] 0 0
2018-004337-32
Secondary ID [2] 0 0
3101-303-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 30 mg
Treatment: Drugs - Atogepant 60 mg
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.

Active comparator: Atogepant 30 mg BID - Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.

Active comparator: Atogepant 60 mg QD - Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.


Treatment: Drugs: Atogepant 30 mg
Tablets containing 30 mg atogepant

Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg atogepant

Treatment: Drugs: Placebo
30 mg/60 mg tablets containing atogepant-matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
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
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Baseline to Week 12
Secondary outcome [10] 0 0
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
At Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2022
Sample size
Target
Accrual to date
Final
778
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital /ID# 237008 - St Leonards
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital /ID# 236859 - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Guangdong
Country [32] 0 0
China
State/province [32] 0 0
Hebei
Country [33] 0 0
China
State/province [33] 0 0
Henan
Country [34] 0 0
China
State/province [34] 0 0
Jiangsu
Country [35] 0 0
China
State/province [35] 0 0
Jilin
Country [36] 0 0
China
State/province [36] 0 0
Shanghai
Country [37] 0 0
China
State/province [37] 0 0
Shanxi
Country [38] 0 0
China
State/province [38] 0 0
Zhejiang
Country [39] 0 0
China
State/province [39] 0 0
Suzhou
Country [40] 0 0
China
State/province [40] 0 0
Tianjin
Country [41] 0 0
China
State/province [41] 0 0
Wuhan
Country [42] 0 0
Czechia
State/province [42] 0 0
Hradec Kralove
Country [43] 0 0
Czechia
State/province [43] 0 0
Kladno
Country [44] 0 0
Czechia
State/province [44] 0 0
Ostrava
Country [45] 0 0
Czechia
State/province [45] 0 0
Prague 10
Country [46] 0 0
Czechia
State/province [46] 0 0
Prague 4
Country [47] 0 0
Czechia
State/province [47] 0 0
Prague
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha
Country [49] 0 0
Czechia
State/province [49] 0 0
Zlin
Country [50] 0 0
Denmark
State/province [50] 0 0
Hovedstaden
Country [51] 0 0
France
State/province [51] 0 0
Bouches-du-Rhone
Country [52] 0 0
France
State/province [52] 0 0
Haute-Savoie
Country [53] 0 0
France
State/province [53] 0 0
Bron
Country [54] 0 0
France
State/province [54] 0 0
Clermont Ferrand
Country [55] 0 0
Germany
State/province [55] 0 0
Berlin
Country [56] 0 0
Germany
State/province [56] 0 0
Essen
Country [57] 0 0
Germany
State/province [57] 0 0
Hamburg
Country [58] 0 0
Germany
State/province [58] 0 0
Kassel
Country [59] 0 0
Germany
State/province [59] 0 0
Kiel
Country [60] 0 0
Germany
State/province [60] 0 0
München
Country [61] 0 0
Italy
State/province [61] 0 0
Bari
Country [62] 0 0
Italy
State/province [62] 0 0
Florence
Country [63] 0 0
Italy
State/province [63] 0 0
Milan
Country [64] 0 0
Italy
State/province [64] 0 0
Napoli
Country [65] 0 0
Italy
State/province [65] 0 0
Pavia
Country [66] 0 0
Italy
State/province [66] 0 0
Rome
Country [67] 0 0
Japan
State/province [67] 0 0
Ehime
Country [68] 0 0
Japan
State/province [68] 0 0
Fukui
Country [69] 0 0
Japan
State/province [69] 0 0
Hokkaido
Country [70] 0 0
Japan
State/province [70] 0 0
Hyogo
Country [71] 0 0
Japan
State/province [71] 0 0
Kagoshima
Country [72] 0 0
Japan
State/province [72] 0 0
Kanagawa
Country [73] 0 0
Japan
State/province [73] 0 0
Kochi
Country [74] 0 0
Japan
State/province [74] 0 0
Miyagi
Country [75] 0 0
Japan
State/province [75] 0 0
Saitama
Country [76] 0 0
Japan
State/province [76] 0 0
Shizuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Tochigi
Country [78] 0 0
Japan
State/province [78] 0 0
Tokyo
Country [79] 0 0
Japan
State/province [79] 0 0
Yamanashi
Country [80] 0 0
Japan
State/province [80] 0 0
Hiroshima
Country [81] 0 0
Japan
State/province [81] 0 0
Kyoto
Country [82] 0 0
Japan
State/province [82] 0 0
Osaka
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Gyeonggido
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul Teugbyeolsi
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Busan
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Seoul
Country [87] 0 0
Poland
State/province [87] 0 0
Kujawsko-pomorskie
Country [88] 0 0
Poland
State/province [88] 0 0
Lubelskie
Country [89] 0 0
Poland
State/province [89] 0 0
Malopolskie
Country [90] 0 0
Poland
State/province [90] 0 0
Pomorskie
Country [91] 0 0
Poland
State/province [91] 0 0
Slaskie
Country [92] 0 0
Poland
State/province [92] 0 0
Wielkopolskie
Country [93] 0 0
Poland
State/province [93] 0 0
Zachodniopomorskie
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Tatarstan, Respublika
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Moscow
Country [96] 0 0
Spain
State/province [96] 0 0
A Coruna
Country [97] 0 0
Spain
State/province [97] 0 0
Navarra
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
Sevilla
Country [100] 0 0
Spain
State/province [100] 0 0
Valencia
Country [101] 0 0
Spain
State/province [101] 0 0
Valladolid
Country [102] 0 0
Spain
State/province [102] 0 0
Zaragoza
Country [103] 0 0
Sweden
State/province [103] 0 0
Helsingborg
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taichung City
Country [105] 0 0
Taiwan
State/province [105] 0 0
Tainan City
Country [106] 0 0
Taiwan
State/province [106] 0 0
Tainan
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei City
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Liverpool
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit, please refer to the link below.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03855137