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)

Phase 3

Completed

Conditions: Episodic migraine
Headache
10019231

Registration Number: NL-OMON52713

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1.01 Male or female participants ages 18 (or age of legal majority) to 80
years, inclusive, at Visit 1
2.01 At least a 1-year history of migraine with or without aura consistent with
a diagnosis according to the ICHD-3, 2018.
2.02 Age of the participant at the time of migraine onset < 50 years
2.03 History of 4 to 14 migraine days per month on average in the 3 months
prior to Visit 1 in the investigator's judgment
2.04 4 to 14 migraine days in the 28-day baseline period per eDiary (Note: A
randomization cap of 20% will be instituted to ensure that the planned
randomized participants include no more than 20% of participants with 4 to <8
migraine days at baseline.)
2.05 Completed at least 20 out of 28 days in the eDiary during the baseline
period and is able to read, understand, and complete the study questionnaires
and eDiary per investigator's judgment.
2.06 Participants must meet both criteria below (ie, a and b). Participants
must have:
a. Failed oral migraine prophylaxis medications from 2 to 4 of the medication
classes as listed below:
i. Propranolol, metoprolol, atenolol, bisoprolol, timolol, or nadolol;
ii. Topiramate;
iii. Flunarizine;
iv. Valproate or divalproex;
v. Amitriptyline or nortriptyline;
vi. Venlafaxine or desvenlafaxine;
vii. Lisinopril;
viii. Candesartan;
ix. Locally approved products (eg, oxeterone or pizotifen)
b. Failed at least one treatment from the list below:
i. Propranolol OR metoprolol;
ii. Topiramate;
iii. Flunarizine;
iv. Amitriptyline

3.01 Male participants willing to minimize the risk of inducing pregnancy as
detailed below:
A male participant must agree to use contraception during the intervention
period and for at least 3 days after the last dose of study intervention and
refrain from donating sperm during this period.
Female participants willing to minimize the risk of inducing pregnancy as
detailed below:
A female participant is eligible to participate if she is not pregnant (ie, has
a negative urine pregnancy result at the Screening Visit (Visit 1) and
Randomization Visit (Visit 2), is not planning to become pregnant during the
course of the study, is not breastfeeding, and fulfills at least one of the
following conditions:
a. Not a WOCBP as defined in Appendix 7 of the protocol
OR
b. A WOCBP who agrees to follow the contraceptive guidance of using a medically
acceptable and effective contraceptive method as defined in
Appendix 7 of the protocol during the intervention period and for 3 days after
the last dose of study intervention.
4.01 Written informed consent and participant privacy information (eg, Written
Authorization for Use and Release of Health and Research Study Information [US
sites] and written Data Protection consent [EU sites]) obtained from the
participant prior to any study-related procedures.

Exclusion Criteria

1.01 Any clinically significant hematologic, endocrine, pulmonary, hepatic,
gastrointestinal, or neurologic disease
1.02 Participant has any other concurrent pain condition that, in the opinion
of the investigator, may significantly impact the current headache disorder
1.03 In the opinion of the investigator, confounding psychiatric conditions,
dementia, epilepsy, or significant neurological disorders other than migraine
1.04 History of malignancy in the 5 years prior to Visit 1, except for
adequately treated basal cell or squamous cell skin cancer, or in situ cervical
cancer
1.05 History of any prior gastrointestinal procedures or gastrointestinal
conditions that may affect the absorption or metabolism of study intervention;
participants with prior gastric bariatric interventions which have been
reversed are not excluded
1.06 Clinically significant cardiovascular or cerebrovascular disease per the
investigator's opinion
1.07 Significant risk of self-harm based on clinical interview and responses on
the C-SSRS, or of harm to others in the opinion of the investigator;
participants must be excluded if they report suicidal ideation with intent,
with or without a plan, in the past 6 months or report suicidal behavior in the
6 months prior to Visit 1 or Visit 2 assessments
1.08 At Visit 1, a user of recreational or illicit drugs or has had a history
within the past year of drug or alcohol abuse or dependence
2.01 Has >= 15 headache days per month on average across the 3 months prior to
Visit 1 in the investigator's judgment
2.02 Has >= 15 headache days in the 28-day baseline period per eDiary
2.03 Difficulty distinguishing migraine headaches from tension-type or other
headaches
2.04 Has a history of migraine accompanied by diplopia or decreased level of
consciousness or retinal migraine as defined by ICHD-3, 2018
2.05 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
3.01 Usage during 30 days prior to Visit 1 and throughout the study period of
and requirement for any medication, diet, or nonpharmacological treatment that
is on the list of prohibited concomitant medications or treatments that cannot
be discontinued or switched to an allowable alternative medication or
treatment. This includes concomitant medications with demonstrated efficacy for
the prevention of migraine regardless of indication.
3.02 Usage of therapeutic or cosmetic botulinum toxin injections into areas of
the head, face, or neck within 6 months prior to Visit 1 and throughout the
study period.
3.03 Usage of barbiturate-containing or opioid-containing analgesics > 2
days/month, triptans or ergots >= 10 days/month, or simple analgesics (eg,
aspirin, NSAIDs, acetaminophen) >= 15 days/month in the 3 months prior to Visit
1 per investigator*s judgment, or during the baseline period.
(Note: barbiturate-containing analgesics are excluded 30 days prior to
screening, during the screening/baseline period, and for the duration of the
study. Opioid-containing analgesics are excluded during the screening/baseline
period and throughout the study, however, episodic use of opioids for purposes
not related to migraine or headache, eg, surger

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from Baseline (CFB) in mean monthly migraine days across the 12-week<br /><br>treatment period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Achievement of at least a 50% reduction in mean monthly migraine days across<br /><br>the 12-week treatment period.<br /><br>- CFB in mean monthly headache days across the 12 week treatment period.<br /><br>- CFB in mean monthly acute medication use days across the 12-week treatment<br /><br>period.<br /><br>- CFB in MSQ v2.1 Role Function-Restrictive domain score at Week 12<br /><br>- CFB in mean monthly Physical Impairment domain score of the AIM-D across the<br /><br>12 week treatment period<br /><br>- CFB in the HIT-6 total score at Week 12</p><br>