Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
NCT ID: NCT04084314
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
701 participants
INTERVENTIONAL
2019-09-30
2023-03-13
Brief Summary
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Detailed Description
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The study design consisted of 3 parts:
* Screening Epoch (0 - 2 weeks): required for all patients to assess initial eligibility. Eligible patients came from study CAMG334ADE01 (NCT03828539).
* Open-label Treatment Epoch (128 weeks): Individual patients were treated for 128 weeks. In this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit. Additionally, a voluntary single treatment interruption ('drug holiday') of up to 24 weeks (approximately six months) could be introduced after at least 12 weeks of treatment in the open-label Treatment Epoch.
* Follow-up Epoch (4 weeks): A Follow-Up Visit 4 weeks after the last regular study visit (8 weeks after last investigational medicinal product \[IMP\] application) was required as part of routine safety monitoring.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Erenumab
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
Erenumab
Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Interventions
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Erenumab
Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is capable of understanding the nature, significance and implications of the clinical trial.
* Adults ≥18 years of age upon entry into screening
Exclusion Criteria
18 Years
67 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany
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Marburg Wehrda, Germany, Germany
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Hanover, Lower Saxony, Germany
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Aachen, North Rhine-Westphalia, Germany
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Alzenau in Unterfranken, , Germany
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Bad Homburg, , Germany
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Bad Honnef, , Germany
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Bad Saarow, , Germany
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Bayreuth, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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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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Bonn, , Germany
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Bonn, , Germany
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Böblingen, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Dillingen, , Germany
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Erbach im Odenwald, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Gelsenkirchen, , Germany
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Greifswald, , Germany
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Haar, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Hoppegarten, , Germany
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Ibbenbueren, , Germany
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Jena, , Germany
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Jülich, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Königstein im Taunus, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lünen, , Germany
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Mannheim, , Germany
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Mittweida, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Neu-Ulm, , Germany
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Neuburg an der Donau, , Germany
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Osnabrück, , Germany
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Pforzheim, , Germany
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Quakenbrück, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Rülzheim, , Germany
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Schwerin, , Germany
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Schwerin, , Germany
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Seesen, , Germany
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Siegen, , Germany
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Sindelfingen, , Germany
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Stadtroda, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Trier, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Unterhaching, , Germany
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Westerstede Oldenburg, , Germany
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Wiesbaden, , Germany
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Würzburg, , Germany
Countries
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References
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Gobel H, Schlegel E, Jaeger K, Ortler S, Leist L. Assessment of prolonged safety and tolerability of erenumab in migraine patients in a long-term open-label study (APOLLON). J Headache Pain. 2024 Sep 25;25(1):157. doi: 10.1186/s10194-024-01860-w.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2019-002201-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMG334ADE03
Identifier Type: -
Identifier Source: org_study_id
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