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

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ClinicalTrials.gov Identifier: NCT03700320
Recruitment Status : Completed
First Posted : October 9, 2018
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate 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: Standard of Care (SOC) Migraine Preventive Medication Drug: Atogepant Phase 3

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Study Type : Interventional
Actual Enrollment : 744 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
Actual Primary Completion Date : May 21, 2020
Actual Study Completion Date : May 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Oral SOC Migraine Preventive Medication
Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
Drug: Standard of Care (SOC) Migraine Preventive Medication
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.

Experimental: Atogepant 60 mg
Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Drug: Atogepant
Atogepant tablets taken orally, once daily for 52 weeks.




Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up ]
    Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.

  2. Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator [ Time Frame: Up to Week 52 ]
    A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.

  3. Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) ]
    Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.

  4. Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior [ Time Frame: Up to Week 52 ]
    The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.



Information from the National Library of Medicine

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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 (e.g., 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 migraine prevention medications and the participant is willing to accept SOC 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 chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., 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 (e.g., aspirin, nonsteroidal anti-inflammatory drugs (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, gastrointestinal (GI), or neurologic disease
  • Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (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 (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700320


Locations
Show Show 112 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joel Trugman, MD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] April 24, 2020
Statistical Analysis Plan  [PDF] June 23, 2020

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03700320    
Other Study ID Numbers: 3101-302-002
First Posted: October 9, 2018    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: May 2021

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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