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Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03939312
Recruitment Status : Completed
First Posted : May 6, 2019
Results First Posted : May 12, 2022
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Atogepant Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 685 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label 40-week Extension 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 : May 6, 2019
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Atogepant 60 mg
Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
Drug: Atogepant
Atogepant Tablets




Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) [ Time Frame: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator [ Time Frame: Up to Week 44 ]
    Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.

  2. Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator [ Time Frame: Up to Week 40 ]
    12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  3. Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator [ Time Frame: Up to Week 44 ]
    PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  4. Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44 ]
    C-SSRS is 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. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.



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 (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.
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.
  • Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).

Exclusion Criteria:

  • 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 at Visit 1.
  • Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1.
  • Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

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): NCT03939312


Locations
Show Show 113 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] September 15, 2020
Statistical Analysis Plan  [PDF] April 30, 2021

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03939312    
Other Study ID Numbers: 3101-309-002
First Posted: May 6, 2019    Key Record Dates
Results First Posted: May 12, 2022
Last Update Posted: May 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 and 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below.
Access Criteria: 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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Migraine
Aura
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases