To Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

Safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year

Condition or disease	Intervention/treatment	Phase
Episodic Migraine	Drug: Atogepant 60 mg; Drug: Standard of Care (SOC) Migraine Prevention Medication	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	700 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine.
Actual Study Start Date :	October 8, 2018
Estimated Primary Completion Date :	June 22, 2020
Estimated Study Completion Date :	November 9, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Atogepant 60 mg; Taken once daily	Drug: Atogepant 60 mg; Tablets containing atogepant 60 mg
Active Comparator: Oral SOC migraine prevention medication; Taken once daily	Drug: Standard of Care (SOC) Migraine Prevention Medication; Medication recognized as safe and effective for the prevention of migraine

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: Across the 52-week treatment period ]

Secondary Outcome Measures :

1. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
2. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
3. Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
4. Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales [ Time Frame: Across the 52-week treatment period ]

   A clinician-rated instrument that reports the severity of both suicidal ideation and behavior.

   Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent).

   Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.

   (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC (Standard of Care) migraine prevention medications and the participant is willing to accept SOC (Standard of Care) treatment.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
• At least a 1-year history of migraine with or without aura consistent with a diagnosis
• 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

Exclusion Criteria:

• Difficulty distinguishing migraine headaches from tension-type or other headaches
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
• Has a current diagnosis of CM, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
• ≥ 15 headache days per month on average across the 3 months prior to Visit 1
• Usage of opioids or barbiturates > 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. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
• Female participant 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
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, GI, or neurologic disease
• Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
• 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
• History of any GI prior procedures or GI conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded.

Contacts and Locations

Contacts

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Contact: Team	877-277-8566	IR-CTRegistration@allergan.com

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Sponsors and Collaborators

Allergan

Investigators

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Study Director:	Joel Trugman, MD	Allergan

More Information

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Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT03700320 History of Changes
Other Study ID Numbers:	3101-302-002
First Posted:	October 9, 2018
Last Update Posted:	March 8, 2019
Last Verified:	March 2019

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Migraine Disorders; Headache Disorders, Primary; Headache Disorders	Brain Diseases; Central Nervous System Diseases; Nervous System Diseases