Monoclonal Antibody Tops Placebo for Reducing Migraine Frequency
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Sept. 4, 2024 -- The humanized monoclonal antibody directed against the pituitary adenylate cyclase-activating polypeptide (PACAP) ligand, Lu AG09222, is better than placebo for reducing migraine frequency over four weeks, according to a study published in the Sept. 5 issue of the New England Journal of Medicine.
Messoud Ashina, M.D., from Copenhagen University Hospital in Denmark, and colleagues conducted a phase 2, double-blind trial involving adults with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a four-week treatment period and eight-week follow-up period. Participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo (97, 46, and 94 individuals, respectively).
The researchers found that in the overall population, the mean number of migraine days per month was 16.7, and the mean change from baseline over weeks 1 through 4 was −6.2 and −4.2 days in the Lu AG09222 750-mg group and placebo group, respectively (difference, −2.0 days). During the 12-week observation period, adverse events with a higher incidence in the Lu AG09222 750-mg group versus the placebo group included COVID-19 (7 versus 3 percent), nasopharyngitis (7 versus 4 percent), and fatigue (5 versus 1 percent).
"This finding establishes proof of concept, supporting the notion that inhibition of PACAP signaling by Lu AG09222 represents a potentially effective mechanism for migraine prevention," the authors write.
The study was partially funded by H. Lundbeck, which is developing Lu AG09222.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted September 2024
Read this next
Review Compares Drug Interventions for Acute Migraine Treatment
MONDAY, Sept. 23, 2024 -- All active interventions show superior efficacy to placebo for freedom from pain, and most do for sustained pain freedom, for the acute treatment of...
Erenumab Effective for Nonopioid Medication Overuse Headache in Chronic Migraine
WEDNESDAY, Sept. 18, 2024 -- Monthly use of erenumab injections (140 mg) is safe and effective in achieving medication overuse headache (MOH) remission in patients with nonopioid...
Ubrogepant Administered During Prodrome Beneficial for Migraine
WEDNESDAY, Aug. 28, 2024 -- For adults experiencing migraine attacks with moderate-to-severe headache pain, ubrogepant administered during prodrome is beneficial for...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.