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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740827




Registration number
NCT04740827
Ethics application status
Date submitted
2/02/2021
Date registered
5/02/2021

Titles & IDs
Public title
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
Secondary ID [1] 0 0
2019-003448-58
Secondary ID [2] 0 0
3101-304-002
Universal Trial Number (UTN)
Trial acronym
ELEVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episodic 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 60 mg
Treatment: Drugs - Placebo

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

Active comparator: Atogepant 60 mg - Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.


Treatment: Drugs: Atogepant 60 mg
Atogepant tablets.

Treatment: Drugs: Placebo
Atogepant matching placebo tablets.
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
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 OTHE Population
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
Timepoint [9] 0 0
Baseline to Week 12
Secondary outcome [10] 0 0
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
Timepoint [10] 0 0
Baseline to Week 12
Secondary outcome [11] 0 0
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
Timepoint [11] 0 0
Baseline to Week 12
Secondary outcome [12] 0 0
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [12] 0 0
From first dose of study drug until 30 days after last dose of study drug (up to Week 12)

Eligibility
Key inclusion criteria
* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
* Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
* 4 to 14 migraine days in the 28-day baseline period per eDiary
* Failed oral migraine prophylaxis medications from 2 to 4 medication classes
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
* Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
* In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
* 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
* Clinically significant cardiovascular or cerebrovascular disease
* 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, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018

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

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
5/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/08/2022
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health /ID# 226341 - Melbourne
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital /ID# 226402 - Parkville
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Chocen
Country [18] 0 0
Czechia
State/province [18] 0 0
Kladno
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czechia
State/province [20] 0 0
Plzen
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague 10
Country [22] 0 0
Czechia
State/province [22] 0 0
Prague 4
Country [23] 0 0
Czechia
State/province [23] 0 0
Prague
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha
Country [25] 0 0
Czechia
State/province [25] 0 0
Rychnov nad Kneznou
Country [26] 0 0
Czechia
State/province [26] 0 0
Zlin
Country [27] 0 0
Denmark
State/province [27] 0 0
Hovedstaden
Country [28] 0 0
France
State/province [28] 0 0
Alpes-Maritimes
Country [29] 0 0
France
State/province [29] 0 0
Loire
Country [30] 0 0
France
State/province [30] 0 0
Nord
Country [31] 0 0
France
State/province [31] 0 0
Clermont Ferrand
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
Germany
State/province [33] 0 0
Baden-Wuerttemberg
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Dresden
Country [36] 0 0
Germany
State/province [36] 0 0
Essen
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Germany
State/province [37] 0 0
Hannover
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Germany
State/province [38] 0 0
Jena
Country [39] 0 0
Germany
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Kassel
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Germany
State/province [40] 0 0
Kiel
Country [41] 0 0
Germany
State/province [41] 0 0
Leipzig
Country [42] 0 0
Germany
State/province [42] 0 0
Mittweida
Country [43] 0 0
Germany
State/province [43] 0 0
Rostock
Country [44] 0 0
Germany
State/province [44] 0 0
Ulm
Country [45] 0 0
Germany
State/province [45] 0 0
Unterhaching
Country [46] 0 0
Germany
State/province [46] 0 0
Westerstede
Country [47] 0 0
Germany
State/province [47] 0 0
Wiesbaden
Country [48] 0 0
Hungary
State/province [48] 0 0
Heves
Country [49] 0 0
Hungary
State/province [49] 0 0
Komarom-Esztergom
Country [50] 0 0
Hungary
State/province [50] 0 0
Somogy
Country [51] 0 0
Hungary
State/province [51] 0 0
Budapest
Country [52] 0 0
Hungary
State/province [52] 0 0
Szeged
Country [53] 0 0
Italy
State/province [53] 0 0
L Aquila
Country [54] 0 0
Italy
State/province [54] 0 0
Lazio
Country [55] 0 0
Italy
State/province [55] 0 0
Bologna
Country [56] 0 0
Italy
State/province [56] 0 0
Florence
Country [57] 0 0
Italy
State/province [57] 0 0
Milan
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Italy
State/province [59] 0 0
Pavia
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Netherlands
State/province [60] 0 0
Groningen
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Netherlands
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Nijmegen
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Netherlands
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Terneuzen
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Poland
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Dolnoslaskie
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Poland
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Kujawsko-pomorskie
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Poland
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Lodzkie
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Poland
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Lubelskie
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Malopolskie
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Poland
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Mazowieckie
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Poland
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Pomorskie
Country [70] 0 0
Poland
State/province [70] 0 0
Slaskie
Country [71] 0 0
Poland
State/province [71] 0 0
Wielkopolskie
Country [72] 0 0
Poland
State/province [72] 0 0
Zachodniopomorskie
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Bashkortostan, Respublika
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Tatarstan, Respublika
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow
Country [76] 0 0
Spain
State/province [76] 0 0
Cantabria
Country [77] 0 0
Spain
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Castellon
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
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Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Spain
State/province [81] 0 0
Zaragoza
Country [82] 0 0
Sweden
State/province [82] 0 0
Stockholms Lan
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Glasgow
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Guildford
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Inverness
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Leeds
Country [87] 0 0
United Kingdom
State/province [87] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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 https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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/NCT04740827