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Completed

NCT Number: NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

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

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Key information

Conditions

Migraine, With or Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Radiant Research, Inc., Birmingham, Alabama, United States

Loading trial locations.

About this study

Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ubrogepant

Drug

Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Placebo-matching Ubrogepant

Drug

Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.

Usual Care

Drug

Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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