Phase 3
Completed N=1,254
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Source: ClinicalTrials.gov NCT02873221 ↗Enrolled (actual)
1,254
Serious AEs
3.1%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event — 65; 66.3; 72.6 Percentage of Participants
◆ Published Evidence
Established
23citations · ~6 / year
Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.
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.
Linked Publications (2)
-
Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.
-
Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1 Treatment Emergent Adverse Event |
65; 66.3; 72.6 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Measurements |
11; 20; 12; 0; 0; 1 | — |
| SECONDARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales |
5; 3; 2; 0; 0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02873221) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.