| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06417775 | Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine | PHASE3 | RECRUITING | 496 | — | — | Sep 10, 2024 | Sep 1, 2027 | Jun 2, 2026 | 106 | United States, Puerto Rico |
| NCT05127954 | Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17) | PHASE3 | ENROLLING BY_INVITATION | 1,200 | — | — | Jan 14, 2022 | Jan 1, 2028 | Jul 20, 2025 | 113 | United States, Puerto Rico |
| NCT05125302 | Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) | PHASE3 | RECRUITING | 1,059 | — | — | Jan 13, 2022 | May 1, 2027 | Jun 5, 2026 | 129 | United States, Puerto Rico |
| NCT04492020 | Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants | PHASE3 | COMPLETED | 518 | — | — | Aug 21, 2020 | Apr 19, 2022 | May 31, 2023 | 73 | United States |
| NCT04179474 | Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine | PHASE1 | COMPLETED | 40 | — | — | Sep 26, 2019 | Dec 23, 2019 | Mar 10, 2021 | 2 | United States |
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).
Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.
Tanner's staging is used to assess growth and pubertal development.
The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Period: Ubrogepant | EXPERIMENTAL | Participants will receive ubrogepant during the double-blind period. |
| Double-Blind Period: Placebo for Ubrogepant | EXPERIMENTAL | Participants will receive placebo during the double-blind period. |
| Open-Label Extension Period: Ubrogepant | EXPERIMENTAL | Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period. |
| Ubrogepant Dose A (12 to 17 Years Old) | EXPERIMENTAL | Participants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity. |
| Ubrogepant Dose B (6 to 11 Years Old) | EXPERIMENTAL | Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity. |
| PK Cohort: Ubrogepant Dose A | EXPERIMENTAL | Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. |
| PK Cohort: Ubrogepant Dose B | EXPERIMENTAL | Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. |
| Main Study: Children Ubrogepant Low Dose | EXPERIMENTAL | Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Main Study: Children Ubrogepant High Dose | EXPERIMENTAL | Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Main Study: Children Ubrogepant Placebo | PLACEBO_COMPARATOR | Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Main Study: Adolescents Ubrogepant Low Dose | EXPERIMENTAL | Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Main Study: Adolescents Ubrogepant High Dose | EXPERIMENTAL | Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Main Study: Adolescents Ubrogepant Placebo | PLACEBO_COMPARATOR | Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. |
| Treatment Sequence A | EXPERIMENTAL | Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event |
| Treatment Sequence B | EXPERIMENTAL | Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event |
| Part 1 (Intervention A then B then D) | EXPERIMENTAL | Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions. |
| Part 2 (Intervention A then C then D) | EXPERIMENTAL | Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Ubrogepant | DRUG | Oral Tablets |
| Placebo for Ubrogepant | DRUG | Oral Tablets |
| Placebo-Matching Ubrogepant | DRUG | Oral Tablet |
| Ubrogepant 100 mg | DRUG | For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours |
| Placebo | DRUG | For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours |
| Erenumab | DRUG | Single dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\]. |
| Galcanezumab | DRUG | 2 SC injections of galcanezumab 120 mg \[Intervention C\]. |
Inclusion Criteria: * At least a 1-year history of migraine with or without aura. * Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period. * Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |