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Abstract Details

A Phase 2 Study of Fremanezumab as a Treatment for Posttraumatic Headache in Adult Patients
Headache
Headache Posters (7:00 AM-5:00 PM)
029

Fremanezumab, an approved preventive treatment for migraine, is a potent calcitonin-gene-related peptide (CGRP) binder that blocks both α- and β-CGRP isoforms from binding to the CGRP receptor.

This phase 2 study evaluated efficacy and safety of fremanezumab, (Ajovy, Teva) for the treatment of posttraumatic headache (PTH) in adult patients.

After 4-week baseline, eligible patients (n=87) were randomly assigned to receive either monthly sc injections of fremanezumab (675 mg) or placebo during a 12-week double-blind period. Subsequently, 70 participants continued in a 12-week open-label period. Headache information was captured daily by participants using an electronic diary during baseline and double-blind periods. Primary efficacy endpoint was mean change from baseline in monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab. Safety was evaluated continuously during the double-blind and open-label periods using adverse event reporting, ECGs, clinical laboratory tests and physical examination. 

For the primary efficacy endpoint, patients on fremanezumab did not observe a reduction in moderate-to-severe headache days compared to placebo (p=0.1876, -3.6 and -5.1 days for fremanezumab and placebo groups, respectively); and there were no differences in the secondary endpoints. In the double-blind period, 31 fremanezumab- and 35 placebo-treated patients reported adverse events, mostly injection site reactions. All but one AE in the placebo group were mild or moderate, and no deaths were reported. During all study periods, there were no meaningful changes in the laboratory and clinical examinations and no treatment-emergent anti-CGRP antibody response. 

This study did not demonstrate statistical differences between fremanezumab and placebo treatment for any of the efficacy endpoints. Despite being administered at a higher dose than labeled for migraine, safety data for fremanezumab 675 mg monthly was comparable to placebo administration and consistent with the known safety profile of fremanezumab.

 

Authors/Disclosures
Egilius L H Spierings, MD,PhD (MEDVADIS RESEARCH)
PRESENTER
Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Manistee. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center) Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alergan. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Davies McFarland & Carroll, LLC. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for SHEEHEY FURLONG & BEHM P.C.. The institution of Dr. Silberstein has received research support from Lundbeck. The institution of Dr. Silberstein has received research support from abbvie. The institution of Dr. Silberstein has received research support from lundbeck. Dr. Silberstein has received publishing royalties from a publication relating to health care.
Umer Najib, MD, FAAN (West Virginia University Hospitals) Dr. Najib has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan . The institution of Dr. Najib has received research support from Teva. The institution of Dr. Najib has received research support from Electrocore. The institution of Dr. Najib has received research support from Theranica . The institution of Dr. Najib has received research support from Eli Lilly.
Juline Bryson, MD (Teva Pharmaceuticals) Dr. Bryson has received personal compensation for serving as an employee of Teva Pharmaceuticals. Dr. Bryson has received stock or an ownership interest from Teva .
Nahum Nesher (Tel Aviv Medical Center) Steve Barash has received personal compensation for serving as an employee of Teva. Steve Barash has received stock or an ownership interest from Teva.
Jiang Li Jiang Li has received personal compensation for serving as an employee of teva.
Andrew H. Ahn, MD, PhD (Alnylam Pharmaceuticals) Dr. Ahn has received personal compensation for serving as an employee of Teva Pharmaceuticals.