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

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

• 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

• Percentage of Participants With at Least 1 Treatment Emergent Adverse Event [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

• Number of Participants With Clinically Significant Laboratory Values [56 Weeks]: Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
• Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings [56 Weeks]: ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
• Number of Participants With Clinically Significant Vital Sign Measurements [56 Weeks]: Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
• Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales [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"

Sex: All, ages: 18 Years to 76 Years

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.

Participant flow

Outcome results

• Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (Primary), Number, Percentage of Participants: Usual Care 65; Ubrogepant 50 mg 66.3; Ubrogepant 100 mg 72.6
• Number of Participants With Clinically Significant Laboratory Values (Secondary), Count of participants, Participants: Usual Care 0; Ubrogepant 50 mg 0; Ubrogepant 100 mg 0
• Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings (Secondary), Count of participants, Participants: Usual Care 0; Ubrogepant 50 mg 0; Ubrogepant 100 mg 0
• Number of Participants With Clinically Significant Vital Sign Measurements (Secondary), Count of participants, Participants: Usual Care 11; Ubrogepant 50 mg 20; Ubrogepant 100 mg 12
• Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales (Secondary), Count of participants, Participants: Usual Care 5; Ubrogepant 50 mg 3; Ubrogepant 100 mg 2

Adverse events

Time frame: Adverse events were collected up to 56 weeks.

Serious adverse events by term

Other adverse events by term

77 more sites not listed.

• Results publication: Lipton RB, Dodick DW, Goadsby PJ, Burstein R, Adams AM, Lai J, Yu SY, Finnegan M, Kuang AW, Trugman JM. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain. Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17. PMID 35977836
• Results publication: Blumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7. PMID 34874514

• Study Protocol (PDF, 2018-04-11)
• Statistical Analysis Plan (PDF, 2018-09-04)

• Adele Thorpe, Study director, Allergan