A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
NCT ID: NCT03096834
Last Updated: 2022-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2017-03-20
2021-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo DB
Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of matching placebo
AMG334 140 mg DB
AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch
AMG334 (70 mg) Pre-Filled Syringe (PFS)
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
AMG334 140 mg DB cont on AMG334 140 mg
AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch
AMG334 (70 mg) Pre-Filled Syringe (PFS)
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
Placebo in DB to AMG334 140 mg
Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
AMG334 (70 mg) Pre-Filled Syringe (PFS)
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
Interventions
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AMG334 (70 mg) Pre-Filled Syringe (PFS)
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of matching placebo
Eligibility Criteria
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Inclusion Criteria
* 4-14 days per month of migraine symptoms
* \>=80% diary compliance during the Baseline period
* Failure of previous migraine prophylactic treatments
Exclusion Criteria
* Pregnant or nursing
* History of cluster or hemiplegic headache
* Evidence of seizure or psychiatric disorder
* Score of over 19 on Beck Depression Inventory-2
* Active chronic pain syndrome
* Cardiac or hepatic disease
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Heidelberg, , Australia
Novartis Investigative Site
Innsbruck, , Austria
Novartis Investigative Site
Vienna, , Austria
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Brussels, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Prague, CZE, Czechia
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Czech Republic, , Czechia
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Prague, , Czechia
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Glostrup Municipality, , Denmark
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Helsinki, , Finland
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Helsinki, , Finland
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Turku, , Finland
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Lille, , France
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Marseille, , France
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Nice, , France
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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München, , Germany
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Tübingen, , Germany
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Wiesbaden, , Germany
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Athens, GR, Greece
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Glyfada, , Greece
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Marousi, , Greece
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Bologna, BO, Italy
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Florence, FI, Italy
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Roma, RM, Italy
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Milan, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Sittard-Geleen, BG, Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Hamar, , Norway
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Sandvika, , Norway
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Santander, Cantabria, Spain
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Valladolid, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Fuenlabrada, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Zaragoza, , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Vällingby, , Sweden
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Bad Zurzach, , Switzerland
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Lausanne, , Switzerland
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Zollikon, , Switzerland
Novartis Investigative Site
Brighton, East Sussex, United Kingdom
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002211-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMG334A2301
Identifier Type: -
Identifier Source: org_study_id
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