Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ubrogepant · 9 trials · 3 indications
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.
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.
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
AUCt of Ubrogepant
AUCinf of Ubrogepant
Cmax of Ubrogepant
Tlag of Ubrogepant
Tmax of Ubrogepant
λz of Ubrogepant
t1/2 of Ubrogepant
CL/F of Ubrogepant
Vz/F of Ubrogepant
| 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 |
| Usual Care | ACTIVE_COMPARATOR | 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. |
| Ubrogepant 50 mg | EXPERIMENTAL | 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. |
| Ubrogepant 100 mg | EXPERIMENTAL | 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. |
| Ubrogepant 25 mg | EXPERIMENTAL | 1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. |
| Placebo | PLACEBO_COMPARATOR | 1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. |
| Ubrogepant-Part 1-Dose A | EXPERIMENTAL | Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions. |
| Ubrogepant-Part 1-Dose B | EXPERIMENTAL | Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions. |
| Ubrogepant-Part 2-Dose C | EXPERIMENTAL | Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions. |
| Ubrogepant-Part 2-Dose D | EXPERIMENTAL | Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions. |
| 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 |
| Usual Care | DRUG | Treatment for a migraine as prescribed by the physician as standard of care in clinical practice. |
| 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 | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
Ubrogepant is an investigational small molecule being developed for the acute treatment of migraine, with or without aura, in adults and pediatric patients. It is also being studied for menstrual migraine. Ubrogepant is not FDA approved and remains in clinical development.
Ubrogepant is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the drug's safety and efficacy for migraine treatment across adult and pediatric populations.
Ubrogepant is in Phase 3 clinical development for migraine. While one early Phase 1 study has been completed, the majority of ongoing trials are Phase 3, including studies in pediatric patients and for menstrual migraine. The drug is investigational and not yet approved.
Ubrogepant is being studied in several clinical trials. NCT04179474 is a completed Phase 1 drug-drug interaction study. NCT04492020 is a completed Phase 3 prodrome study. NCT05127954 is an enrolling Phase 3 pediatric extension study. NCT06417775 is an active Phase 3 study in menstrual migraine.
Yes, Ubrogepant is being studied in pediatric patients. NCT05127954 is a Phase 3 long-term extension study assessing safety and tolerability of oral ubrogepant for acute migraine treatment in children ages 6 to 17 years. This trial is enrolling by invitation in the United States and Puerto Rico.
Yes, Ubrogepant is being evaluated for menstrual migraine. NCT06417775 is an active Phase 3 study assessing adverse events and change in disease activity in adult female participants with menstrual migraine. The study is enrolling in the United States and Puerto Rico.