A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine
Overview
- Phase
- Phase 3
- Intervention
- Eptinezumab
- Conditions
- Migraine
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 485
- Locations
- 56
- Primary Endpoint
- Time to Absence of Most Bothersome Symptom (MBS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
Detailed Description
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Greater than 1-year history of migraine, with or without aura, with onset of first migraine before age
- •Migraine on 4 to 15 days per month in the 3 months prior to screening.
- •Headache free for at least 24 hours prior to onset of a qualifying migraine.
Exclusion Criteria
- •Unable to differentiate migraine from other headache or pain disorders.
- •Use of the following medication, for any indication, within the 24-hour period prior to dosing with study drug:
- •triptans, ergotamines and ergot-derivatives
- •analgesics (including but not limited to acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs \[NSAIDs\], combination analgesics, caffeine-containing analgesics, and opioids/narcotics) and other acute migraine medication(s)
- •antiemetic medications (including but not limited to prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide)
- •antihistamines
- •devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections, spinal manipulation)
- •Use of the following medication, for any indication, in each of the 3 months prior to screening:
- •opioids/narcotics or butalbital containing products (including combinations) on more than 4 days per month;
- •triptans, ergotamines, or combination analgesics for 10 or more days per month;
Arms & Interventions
Eptinezumab
Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
Intervention: Eptinezumab
Placebo
Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
Intervention: Placebo
Outcomes
Primary Outcomes
Time to Absence of Most Bothersome Symptom (MBS)
Time Frame: Up to 48 hours postdose
Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).
Time to Headache Pain Freedom
Time Frame: Up to 48 hours postdose
Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
Secondary Outcomes
- Headache Pain Freedom at 4 Hours(4 hours)
- Absence of MBS at 4 Hours(4 hours)
- Headache Pain Freedom at 2 Hours(2 hours)
- Absence of MBS at 2 Hours(2 hours)
- Use of Rescue Medication Within the First 24 Hours(Up to 24 hours postdose)