A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Summary
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
Timeline
- Start
- 2017-03-20
- Primary completion
- 2018-01-18
- Completion
- 2021-01-28
Outcome
Met primary endpoint
registry AMG334 140 mg DB vs Placebo DB; p = 0.002; Odds Ratio (OR) 2.73 (95% CI 1.43 to 5.19) NCT03096834 ↗
registry NUMBER AMG334 140 mg DB: 30.3 Percentage of participants NUMBER Placebo DB: 13.7 Percentage of participants NCT03096834 ↗
release “LIBERTY mit AMG 334, die erste derartige Studie zur Migräneprävention, die speziell mit Patienten nach mehreren erfolglosen Therapieversuchen durchgeführt wurde, erreichte ihren primären Endpunkt.” novartis.com ↗
release “In LIBERTY, patients taking Aimovig 140 mg had significantly higher likelihood of having their migraine days cut by half or more compared to placebo” novartis.com ↗
Publications
- Reuter U, Goadsby PJ, Ferrari MD, Da Silva Lima GP, Mondal S, Kalim J, Hasan F, Wen S, Arkuszewski M, Pandhi S, Stites T, Lanteri-Minet M. Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study. Neurology. 2024 May;102(10):e209349. doi: 10.1212/WNL.0000000000209349. Epub 2024 Apr 26.
- Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
- Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29.
- Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029.
- Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5.
- Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erenumab | Monoclonal antibody | 140 mg | Subcutaneous |