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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
Date last updated
21/09/2023

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
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United States of America
State/province [4] 0 0
Idaho
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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
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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Ohio
Country [12] 0 0
United States of America
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Texas
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United States of America
State/province [13] 0 0
Utah
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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
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France
State/province [31] 0 0
Clermont Ferrand
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France
State/province [32] 0 0
Paris
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Germany
State/province [33] 0 0
Baden-Wuerttemberg
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Hannover
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Germany
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Jena
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Germany
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Kassel
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Mittweida
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Germany
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Rostock
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Germany
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Ulm
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Germany
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Unterhaching
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Germany
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Westerstede
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Germany
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Wiesbaden
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Hungary
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Heves
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Hungary
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Komarom-Esztergom
Country [50] 0 0
Hungary
State/province [50] 0 0
Somogy
Country [51] 0 0
Hungary
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Budapest
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Hungary
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Szeged
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Italy
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L Aquila
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Italy
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Lazio
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Italy
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Bologna
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Italy
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Florence
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Italy
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Milan
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Italy
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Napoli
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Italy
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Pavia
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Netherlands
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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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Kujawsko-pomorskie
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Lodzkie
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Lubelskie
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Malopolskie
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Mazowieckie
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Pomorskie
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Poland
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Slaskie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
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Russian Federation
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Bashkortostan, Respublika
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Moscow
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Spain
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Cantabria
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Spain
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Castellon
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Stockholms Lan
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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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
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.
Trial website
https://clinicaltrials.gov/study/NCT04740827
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04740827