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Trial record 14 of 179 for:    Migraine AND migraine with or without aura

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

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ClinicalTrials.gov Identifier: NCT02873221
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

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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 related topics: Migraine

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.




Primary Outcome Measures :
  1. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: 56 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [ Time Frame: 56 Weeks ]
  2. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [ Time Frame: 56 Weeks ]
  3. Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [ Time Frame: 56 Weeks ]
  4. Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales [ Time Frame: 56 Weeks ]


Information from the National Library of Medicine

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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.

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


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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Adele Thorpe Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02873221     History of Changes
Other Study ID Numbers: UBR-MD-04
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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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