Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

ClinicalTrials.gov Identifier: NCT04084314

Novartis Reference Number: CAMG334ADE03

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab.

Condition 
Migraine
Migraine Disorders
Migraine Headache
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
560 participants
Start date 
Sep 30, 2019
Completion date 
Aug 01, 2022
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

Biological
Erenumab
pre-filled pen (auto-injector)

Eligibility Criteria

Key inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Patient is capable of understanding the nature, significance and implications of the clinical trial.
Adults ≥18 years of age upon entry into screening

Key exclusion Criteria:

Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01
Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.

Study Locations

Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70178
Baden Wuertemberg
Germany
Novartis Investigative Site
Recruiting
Hannover, 30159
Niedersachsen
Germany
Novartis Investigative Site
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Aachen, 52062
Nordrhein-Westfalen
Germany
Novartis Investigative Site
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Alzenau, 63755
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Germany
Novartis Investigative Site
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Bad Homburg, 61348
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Germany
Novartis Investigative Site
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Bad Honnef, 53604
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Germany
Novartis Investigative Site
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Bad Saarow, 15526
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Germany
Novartis Investigative Site
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Bayreuth, 95445
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Germany
Novartis Investigative Site
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Berlin, 10713
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Germany
Novartis Investigative Site
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Berlin, 120999
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Germany
Novartis Investigative Site
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Berlin, 12101
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Germany
Novartis Investigative Site
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Berlin, 12163
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Germany
Novartis Investigative Site
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Berlin, 12627
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Germany
Novartis Investigative Site
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Berlin, 13053
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Germany
Novartis Investigative Site
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Berlin, 13353
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Germany
Novartis Investigative Site
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Berlin, 14169
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Germany
Novartis Investigative Site
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Bielefeld, D 33647
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Germany
Novartis Investigative Site
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Boblingen, 71032
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Germany
Novartis Investigative Site
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Bochum, 44791
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Germany
Novartis Investigative Site
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Bonn, 53111
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Germany
Novartis Investigative Site
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Bonn, 53177
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Germany
Novartis Investigative Site
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Chemnitz, 09117
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Germany
Novartis Investigative Site
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Dillingen, 66763
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Germany
Novartis Investigative Site
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Erbach, 64711
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Germany
Novartis Investigative Site
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Essen, 45133
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Germany
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Essen, 45147
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Germany
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Frankfurt, 60313
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Germany
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Freiburg, 79098
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Germany
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Gelsenkirchen, 45879
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Germany
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Greifswald, 17475
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Germany
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Haar, 85540
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Germany
Novartis Investigative Site
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Halle, 06120
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Germany
Novartis Investigative Site
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Hamburg, 20253
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Germany
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Heidelberg, 69120
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Germany
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Ibbenbueren, 49477
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Germany
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Juelich, 52428
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Germany
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Kassel, 34121
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Germany
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Kassel,
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Germany
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Kiel, 24149
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Germany
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Koln, 50935
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Germany
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Königstein im Taunus, 61462
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Germany
Novartis Investigative Site
Active, not recruiting
Leipzig, 04103
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Germany
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Leipzig, 04103
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Germany
Novartis Investigative Site
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Leipzig, 04107
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Germany
Novartis Investigative Site
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Luenen, 44534
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Germany
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Mannheim, 66163
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Germany
Novartis Investigative Site
Active, not recruiting
Marburg Wehrda, 35041
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Germany
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Mittweida, 09648
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Germany
Novartis Investigative Site
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Muenchen, 81377
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Germany
Novartis Investigative Site
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Muenchen, 81675
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Germany
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Muenster, 48149
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Germany
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Neu-Ulm, 89231
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Germany
Novartis Investigative Site
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Neuburg an der Donau, 86633
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Germany
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Osnabrück, 49074
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Germany
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Pforzheim, 75172
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Germany
Novartis Investigative Site
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Quakenbrueck, 49610
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Germany
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Regensburg, 93059
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Germany
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Rostock, 18057
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Germany
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Ruelzheim, 76761
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Germany
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Schwerin, 19053
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Germany
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Schwerin, 19055
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Germany
Novartis Investigative Site
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Seesen, 38723
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Germany
Novartis Investigative Site
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Siegen, 57076
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Germany
Novartis Investigative Site
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Sindelfingen, 71065
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Germany
Novartis Investigative Site
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Stadtroda, 07646
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Germany
Novartis Investigative Site
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Stuttgart, 70174
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Germany
Novartis Investigative Site
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Stuttgart, 70178
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Germany
Novartis Investigative Site
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Stuttgart, 70182
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Germany
Novartis Investigative Site
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Trier, 54292
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Germany
Novartis Investigative Site
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Tübingen, 72076
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Germany
Novartis Investigative Site
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Ulm, 89073
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Germany
Novartis Investigative Site
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Unterhaching, 82008
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Germany
Novartis Investigative Site
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Westerstede/Oldenburg, 26655
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Germany
Novartis Investigative Site
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Wiesbaden, 65191
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
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Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]