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An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of 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: NCT02873221
Recruitment Status : Completed
First Posted : August 19, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

Condition or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Ubrogepant Drug: Placebo-matching Ubrogepant Drug: Usual Care Phase 3

Detailed Description:
Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura
Actual Study Start Date : September 13, 2016
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Ubrogepant

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Usual Care
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
 Drug: Usual Care
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Experimental: Ubrogepant 50 mg
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
 Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Drug: Placebo-matching Ubrogepant
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
Experimental: Ubrogepant 100 mg
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
 Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Treatment Emergent Adverse Event [ Time Frame: 56 Weeks ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and 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. TEAEs are AEs with an onset that occurs after receiving study drug.


Secondary Outcome Measures :
  1. Number of Participants With Clinically Significant Laboratory Values [ Time Frame: 56 Weeks ]
    Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

  2. Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings [ Time Frame: 56 Weeks ]
    ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

  3. Number of Participants With Clinically Significant Vital Sign Measurements [ Time Frame: 56 Weeks ]
    Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

  4. Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales [ Time Frame: 56 Weeks ]

    On the C-SSRS, the 5 types of suicidal ideation are:

    Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria:

  • Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
  • Requirement for a medication during the study that is on the list of prohibited medications.
Contacts and Locations
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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): NCT02873221


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Adele Thorpe Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] April 11, 2018
Statistical Analysis Plan  [PDF] September 4, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02873221    
Other Study ID Numbers: UBR-MD-04
First Posted: August 19, 2016    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 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