An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

NCT ID: NCT01686581

Last Updated: 2018-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

641 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-23

Study Completion Date

2016-10-12

Brief Summary

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This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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BOTOX®

BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.

botulinum toxin Type A

Intervention Type DRUG

Botulinum toxin Type A (BOTOX®) administered according to physician prescription.

Interventions

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botulinum toxin Type A

Botulinum toxin Type A (BOTOX®) administered according to physician prescription.

Intervention Type DRUG

Other Intervention Names

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BOTOX® onabotulinumtoxin A

Eligibility Criteria

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Inclusion Criteria

\- Prescribed BOTOX® for the prophylaxis of headaches.

Exclusion Criteria

* Received treatment with any botulinum toxin Type A serotype in the last 26 weeks
* Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Nicole Strickling

Aachen, , Germany

Site Status

Manfred Oberling

Bad Camberg, , Germany

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Kathrin Krome

Bamberg, , Germany

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Heike Förster

Baunatal, , Germany

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MVZ Schmerzzentrum Berlin

Berlin, , Germany

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Christoph Engelmann

Berlin, , Germany

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Andreas Kupsch

Berlin, , Germany

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Hans-Dieter Zug

Böblingen, , Germany

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Andreas Schwittay

Böhlen, , Germany

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Bezirksklinikum Mainkofen

Deggendorf, , Germany

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Ulrike Kirchhöfer

Erfurt, , Germany

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Michael Kiszka

Erfurt, , Germany

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Astrid Gendolla

Essen, , Germany

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Jürgen Hamacher

Essen, , Germany

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Schmerzzentrum Rhein Main in Frankfurt

Frankfurt, , Germany

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Bernhard Hellwig

Freiburg im Breisgau, , Germany

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G. Müller-Schwefe

Göppingen, , Germany

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Borries Kukowski

Göttingen, , Germany

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Peter Asmus

Guelders, , Germany

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Veit Becker

Hamburg, , Germany

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Hanno Jaeger

Hamburg, , Germany

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Klaus Gerlach

Hanover, , Germany

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Medizinische Hochschule Hannover

Hanover, , Germany

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Ulrike Köhler

Heidelberg, , Germany

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Frank Halbgewachs

Heidenheim, , Germany

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Dirk Buschmann

Herford, , Germany

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Rotes Kreuz Krankenhaus Kassel

Kassel, , Germany

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Schmerzklinik Kiel

Kiel, , Germany

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Migräne-Klinik Königstein

Königstein, , Germany

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Neuroscience Center Leipzig

Leipzig, , Germany

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Dietmar Walter Noack

Limburgerhof, , Germany

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Lothar Klimpel

Limburgerhof, , Germany

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St.-Marien-Hospital GmbH

Lünen, , Germany

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Olaf Günther

Magdeburg, , Germany

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Institut für Forschung und Prävention

Mainz, , Germany

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Stephan Nautscher-Timmermann

Mühlhausen, , Germany

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Praxis für Neurologie und SchmerzMedizin

München, , Germany

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Matthias Haslbeck

München, , Germany

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Klinikum der Universität München - Großhadern, Neurologische Klinik

München, , Germany

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Neurologie und Kopfschmerzzentrum Münchner Freiheit

München, , Germany

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Schmerztherapiezentrum Münster

Münster, , Germany

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Roland Leger

Nuremberg, , Germany

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Dr. Becker Rhein-Sieg-Klinik

Nümbrecht, , Germany

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Matthias Röder

Oberhausen, , Germany

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mediPlan Klinik GmbH

Ostfildern, , Germany

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Frank Freitag

Potsdam, , Germany

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Universität Rostock, Klinik für Neurologie

Rostock, , Germany

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Ingo Palutke

Stadtroda, , Germany

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Heinz Peter Herbst

Stuttgart, , Germany

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Anselm Kornhuber

Ulm, , Germany

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Universitätsklinikum Ulm, Klinik für Neurologie

Ulm, , Germany

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Volker Heinicke

Weimar, , Germany

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Parkinson-Klinik Wolfach

Wolfach, , Germany

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Michaela Krause

Wolfratshausen, , Germany

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Jochen Ulzheimer

Würzburg, , Germany

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Dorothea Händel

Zwickau, , Germany

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Ospedale Careggi

Florence, , Italy

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Istituto Neurologico Carlo Besta di Milano

Milan, , Italy

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Azienda Ospedaliera Sant'Andrea

Roma, , Italy

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Hodeverket Headache Clinic

Sandnes, , Norway

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LLC Neyroklinika

Khabarovsk, , Russia

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LLC Center for Interdisciplinary Dentistry and Neurology

Moscow, , Russia

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LLC Clinic Sesil +

Moscow, , Russia

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LLC University Headache Clinic

Moscow, , Russia

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LLC Sibneuromed

Novosibirsk, , Russia

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Hospital Universitario de Burgos

Burgos, , Spain

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Hospital Universitario Reina Sofía

Córdoba, , Spain

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Hospital Universitario Virgen de la Victoria

Málaga, , Spain

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Hospital Central de Asturias

Oviedo, , Spain

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Hospital Santiago de Compostela

Santiago de Compostela, , Spain

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Hospital Galdácano

Usansolo, , Spain

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Löfvingkliniken

Gothenburg, , Sweden

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Centralsjukhuset i Karlstad

Karlstad, , Sweden

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Läkarhuset Utsikten

Stockholm, , Sweden

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Spire Hull and East Riding Hospital

Anlaby, , United Kingdom

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University Hospital of North Staffordshire, Neurology Research Unit

Stoke-on-Trent, , United Kingdom

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Mid Yorkshire NHS Trust

Wakefield, , United Kingdom

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Countries

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Germany Italy Norway Russia Spain Sweden United Kingdom

References

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Ahmed F, Gaul C, Kollewe K, Singh RC, Sommer K. Real-World Safety and Efficacy of 156 U - 195 U OnabotulinumtoxinA in Adults With Chronic Migraine: Results From the REPOSE Study. BMC Neurol. 2025 May 6;25(1):197. doi: 10.1186/s12883-025-04087-7.

Reference Type DERIVED
PMID: 40329224 (View on PubMed)

Kollewe K, Gaul C, Gendolla A, Sommer K. Real-life use of onabotulinumtoxinA reduces healthcare resource utilization in individuals with chronic migraine: the REPOSE study. J Headache Pain. 2021 Jun 2;22(1):50. doi: 10.1186/s10194-021-01260-4.

Reference Type DERIVED
PMID: 34078259 (View on PubMed)

Ahmed F, Gaul C, Garcia-Monco JC, Sommer K, Martelletti P; REPOSE Principal Investigators. An open-label prospective study of the real-life use of onabotulinumtoxinA for the treatment of chronic migraine: the REPOSE study. J Headache Pain. 2019 Mar 7;20(1):26. doi: 10.1186/s10194-019-0976-1.

Reference Type DERIVED
PMID: 30845917 (View on PubMed)

Other Identifiers

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MAF/AGN/NS/CM/002

Identifier Type: -

Identifier Source: org_study_id

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