WITH UBRELVY, PATIENTS STOPPED HEADACHE PAIN BEFORE IT STARTED!1
PRODROME TRIAL STUDY RESULTS
Ubrelvy has been studied in patients with migraine who recognized prodrome symptoms of a migraine attack 1 to 6 hours before the headache phase1,2,3, and has been found effective and well tolerated for the treatment of migraine attacks when taken during the prodrome.
UBRELVY HELPED PATIENTS RETAIN NORMAL FUNCTION2
Treatment with Ubrogepant 100 mg during the prodrome was associated with significantly greater ability to function normally over 24 hours compared with placebo (secondary endpoint, geometric mean of the odds ratio vs placebo, 1.66; P<0.0001).
This treatment effect was observed as early as 2 hours post-dose (additional endpoint).2
* Limitation: This study evaluated a subset of the migraine population who could reliably predict the onset of a migraine attack (per clinician judgment) within a short time window. Patients should be carefully assessed on their ability to accurately predict the onset of a migraine attack and progression to the headache phase. The 50 mg dose was not assessed. Patients were not allowed to administer a second dose.
UBRELVY BROUGHT PATIENTS RELIEF BY REDUCING COMMON PRODROMAL SYMPTOMS EFFECTS3
Treatment with Ubrogepant 100 mg during the prodrome ameliorated the common prodromal symptoms compared with placebo over a 48-hour time period (additional endpoint).3
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* Limitation: This study evaluated a subset of the migraine population who could reliably predict the onset of a migraine attack (per clinician judgment) within a short time window. Patients should be carefully assessed on their ability to accurately predict the onset of a migraine attack and progression to the headache phase. The 50 mg dose was not assessed. Patients were not allowed to administer a second dose.
PRODROME TRIAL
FOR PATIENTS WITH MIGRAINE WHO RECOGNIZE PRODROMAL SYMPTOMS OF A MIGRAINE ATTACK 1 TO 6 HOURS BEFORE THE HEADACHE PHASE1
PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER STUDY1
Objective: To determine whether treatment during the initial phase of the migraine attack, prior to the onset of headache, can attenuate the severity of the headache phase and reduce disability.1
Key Inclusion Criteria
- Patients between 18 and 75 years of age with ≥1 year history of migraine (with or without aura)
- Occurrence of 2 to 8 migraine attacks/month with moderate to severe headache
- Current or past use of ≥1 prescription medication for the acute treatment of migraine or preventive treatment
- Migraine onset before 50 years of age
- At least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the ICHD-3
- Migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and episodes are separated by 48 hours
During the screening period, 77% of patients (n=911) reliably identified their prodrome symptoms.
The 5 most common prodromal symptoms experienced during the screening period were§:
- 57% Sensitivity to light
- 50% Tiredness/sleepiness/fatigue
- 42% Neck pain/stiff neck
- 34% Sensitivity to sound
- 28% Dizziness/light-headedness/vertigo/imbalance
Study Design: Screening Period & Double-Blind Treatment Period
Participant Flow1
- 1087 Patients were screened for eligibility
- 479 Patients discontinued due to screening failure; of those, 317 patients failed to meet inclusion criteria, including 290 who failed screening due to qualifying event criteria, including investigator judgment.
- 23 Patients did not routinely experience prodromal symptoms that were reliably followed by headache of any intensity within 1 to 6 hours, per patient history and investigator’s judgment
- 144 Patients recorded <3 or >16 qualifying events during the screening period
- 123 Patients did not reliably experience headache pain of any intensity within 1 to 6 hours following a qualifying event based on collected screening data
Definition of a Qualifying Prodrome Event:1
- A migraine attack with prodromal symptoms in which headache was not present at the time
- The participant had not had a headache in the previous 48 hours
- Treatments for acute headache had not been taken in the previous 48 hours
- The participant was confident a headache would inevitably follow within 1 to 6 hours after experiencing the qualifying prodrome event
§Based on 920 participants who entered eDiary data and includes a total of 4802 qualifying events during the screening period.1
†Patients recorded presymptoms that they were confident would lead to a headache and any headache events in an eDiary. The number of prodromal symptoms is not the same as the number of qualifying events.
‡77% value based on 911 participants who had evaluable data. Of the 1087 patients who were screened for eligibility, 290 failed screening due to qualifying event criteria, including investigator judgment.
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References:
1. Data on file. AbbVie.
Migraine Stages
Migraine is a Complex, Chronic Disease with Recurrent Attacks that are often Incapacitating and Characterized by Headache Pain and Neurologic and Autonomic Symptoms1,2
About the Prodrome Phase
~70% of People with migraine reported experiencing prodrome symptoms of a migraine attack3,4
Common prodrome symptoms may include fatigue, neck stiffness, difficulty concentrating & sensitivity to light and/or sound.
Other pre-headache symptoms may include irritability, yawning, increased need to urinate, food cravings, difficulty speaking or reading, nausea, visual disturbances, numbness and tingling. Pre-headache symptoms may vary between individuals and from attack to attack.3
References:
1. Pietrobon D, et al. Annu Rev Physiol. 2013;75:365-391.
2. https://migrainebuddy.com/the-stages-of-a-migraine-migraine-attack. Accessed January 4, 2024.
3. American Migraine Foundation. Published January 18, 2018. Accessed January 4, 2024. https://americanmigrainefoundation.org/resource-library/timeline-migraine-attack/
4. Lipton RB, et al. Poster presented at: 64th Annual Scientific Meeting of the American Headache Society, June 9-12, 2022; Denver, CO.