Assessment of LBR-101 In Chronic Migraine
Summary
The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.
Timeline
- Start
- 2014-01-31
- Primary completion
- 2015-02-28
- Completion
- 2015-03-31
Outcome
Met primary endpoint
registry Placebo vs LBR-101 Low Dose; p = 0.0386; Mean Difference (Final Values) -22.74 (95% CI -44.28 to -1.21) NCT02021773 ↗
registry Placebo vs LBR-101 High Dose; p = 0.0057; Mean Difference (Final Values) -30.41 (95% CI -51.88 to -8.95) NCT02021773 ↗
release “Results demonstrated that both tested doses of TEV-48125 achieved the primary and secondary efficacy endpoints of the study at one and three months.” tevapharm.com ↗
release “Both assessed doses of TEV-48125 were significantly superior to placebo in reducing, relative to baseline, the number of hours with headache (primary endpoint” tevapharm.com ↗
Publications
- VanderPluym J, Dodick DW, Lipton RB, Ma Y, Loupe PS, Bigal ME. Fremanezumab for preventive treatment of migraine: Functional status on headache-free days. Neurology. 2018 Sep 18;91(12):e1152-e1165. doi: 10.1212/01.wnl.0000544321.19316.40. Epub 2018 Aug 17.
- Halker Singh RB, Aycardi E, Bigal ME, Loupe PS, McDonald M, Dodick DW. Sustained reductions in migraine days, moderate-to-severe headache days and days with acute medication use for HFEM and CM patients taking fremanezumab: Post-hoc analyses from phase 2 trials. Cephalalgia. 2019 Jan;39(1):52-60. doi: 10.1177/0333102418772585. Epub 2018 May 3.
- Cohen JM, Dodick DW, Yang R, Newman LC, Li T, Aycardi E, Bigal ME. Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. Headache. 2017 Oct;57(9):1375-1384. doi: 10.1111/head.13156. Epub 2017 Sep 1.
- Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R, Silberstein SD. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015 Nov;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. Epub 2015 Sep 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fremanezumab | Monoclonal antibody | 225 mg | Subcutaneous |
| Subject | Fremanezumab | Monoclonal antibody | 900 mg | Subcutaneous |