An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine
A 24-month, Prospective, Non-interventional Study to Describe the Long Term, Real-Life Use of BOTOX® for the Symptomatic Treatment of Adults With Chronic Migraine, Measuring Healthcare Resource Utilization, and Patient Reported Outcomes Observed in Practice
1 other identifier
observational
641
7 countries
77
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Longer than P75 for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2012
CompletedFirst Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2016
CompletedResults Posted
Study results publicly available
November 9, 2018
CompletedNovember 9, 2018
April 1, 2018
4.2 years
September 13, 2012
April 6, 2018
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Admitted to the Hospital for Headache
The Baseline value included participants who had been admitted to the hospital for headache in the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included participants who been admitted to the hospital for headache since the previous visit.
Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]
Mean Number of Days of Headache-related Hospital Admissions
The number of admission days is presented as the mean, normalized to a period of 90 days. The Baseline value included admissions during the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included admissions since the second-to-last visit.
Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]
Percentage of Participants Who Visited Any Healthcare Professional (HCP)
The Baseline value included participants who had visited an HCP in the last 3 months prior to the baseline visit (first administration of Botox); the value for FU last included participants who visited an HCP since the second-to-last visit.
Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]
Secondary Outcomes (5)
Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]
Change From Baseline in the EQ-5D Questionnaire Total Score
Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
Change From Baseline in the Health State Score of the EQ-5D Questionnaire
Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
Change From Baseline in the Number of Headache Days
Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale
ADM last [median 20.30 months]
Study Arms (1)
BOTOX®
BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
Interventions
Botulinum toxin Type A (BOTOX®) administered according to physician prescription.
Eligibility Criteria
Patients with chronic migraine prescribed BOTOX® for the prophylaxis of headaches
You may qualify if:
- \- Prescribed BOTOX® for the prophylaxis of headaches.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (77)
Nicole Strickling
Aachen, 52062, Germany
Manfred Oberling
Bad Camberg, 65520, Germany
Kathrin Krome
Bamberg, 96052, Germany
Heike Förster
Baunatal, 34225, Germany
MVZ Schmerzzentrum Berlin
Berlin, 10435, Germany
Christoph Engelmann
Berlin, 12099, Germany
Andreas Kupsch
Berlin, 14052, Germany
Hans-Dieter Zug
Böblingen, 90489, Germany
Andreas Schwittay
Böhlen, 04564, Germany
Bezirksklinikum Mainkofen
Deggendorf, 94469, Germany
Ulrike Kirchhöfer
Erfurt, 48143, Germany
Michael Kiszka
Erfurt, 99084, Germany
Astrid Gendolla
Essen, 45133, Germany
Jürgen Hamacher
Essen, 45219, Germany
Schmerzzentrum Rhein Main in Frankfurt
Frankfurt, 60313, Germany
Bernhard Hellwig
Freiburg im Breisgau, 79098, Germany
G. Müller-Schwefe
Göppingen, 73033, Germany
Borries Kukowski
Göttingen, 37073, Germany
Peter Asmus
Guelders, 47608, Germany
Veit Becker
Hamburg, 20249, Germany
Hanno Jaeger
Hamburg, 22767, Germany
Klaus Gerlach
Hanover, 30167, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Ulrike Köhler
Heidelberg, 69115, Germany
Frank Halbgewachs
Heidenheim, 89518, Germany
Dirk Buschmann
Herford, 32049, Germany
Rotes Kreuz Krankenhaus Kassel
Kassel, 34121, Germany
Schmerzklinik Kiel
Kiel, 24149, Germany
Migräne-Klinik Königstein
Königstein, 61462, Germany
Neuroscience Center Leipzig
Leipzig, 04275, Germany
Dietmar Walter Noack
Limburgerhof, 67117, Germany
Lothar Klimpel
Limburgerhof, 67117, Germany
St.-Marien-Hospital GmbH
Lünen, 44534, Germany
Olaf Günther
Magdeburg, 39116, Germany
Institut für Forschung und Prävention
Mainz, 55116, Germany
Stephan Nautscher-Timmermann
Mühlhausen, 99974, Germany
Praxis für Neurologie und SchmerzMedizin
München, 80331, Germany
Matthias Haslbeck
München, 80807, Germany
Klinikum der Universität München - Großhadern, Neurologische Klinik
München, 81377, Germany
Neurologie und Kopfschmerzzentrum Münchner Freiheit
München, 81667, Germany
Schmerztherapiezentrum Münster
Münster, 48143, Germany
Roland Leger
Nuremberg, 90489, Germany
Dr. Becker Rhein-Sieg-Klinik
Nümbrecht, 51588, Germany
Matthias Röder
Oberhausen, 46145, Germany
mediPlan Klinik GmbH
Ostfildern, 73760, Germany
Frank Freitag
Potsdam, 14467, Germany
Universität Rostock, Klinik für Neurologie
Rostock, 18147, Germany
Ingo Palutke
Stadtroda, 07646, Germany
Heinz Peter Herbst
Stuttgart, 70718, Germany
Anselm Kornhuber
Ulm, 89073, Germany
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, 89081, Germany
Volker Heinicke
Weimar, 99423, Germany
Parkinson-Klinik Wolfach
Wolfach, 77709, Germany
Michaela Krause
Wolfratshausen, 82515, Germany
Jochen Ulzheimer
Würzburg, 97074, Germany
Dorothea Händel
Zwickau, 80560, Germany
Ospedale Careggi
Florence, 50139, Italy
Istituto Neurologico Carlo Besta di Milano
Milan, 20133, Italy
Azienda Ospedaliera Sant'Andrea
Roma, 00189, Italy
Hodeverket Headache Clinic
Sandnes, 4319, Norway
LLC Neyroklinika
Khabarovsk, 680000, Russia
LLC Center for Interdisciplinary Dentistry and Neurology
Moscow, 119146, Russia
LLC Clinic Sesil +
Moscow, 125047, Russia
LLC University Headache Clinic
Moscow, 129090, Russia
LLC Sibneuromed
Novosibirsk, 630091, Russia
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Central de Asturias
Oviedo, 33006, Spain
Hospital Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Galdácano
Usansolo, 48960, Spain
Löfvingkliniken
Gothenburg, 41120, Sweden
Centralsjukhuset i Karlstad
Karlstad, 65230, Sweden
Läkarhuset Utsikten
Stockholm, 11628, Sweden
Spire Hull and East Riding Hospital
Anlaby, HU10 7AZ, United Kingdom
University Hospital of North Staffordshire, Neurology Research Unit
Stoke-on-Trent, ST4 6QG, United Kingdom
Mid Yorkshire NHS Trust
Wakefield, WF1 4DG, United Kingdom
Related Publications (3)
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.
PMID: 40329224DERIVEDKollewe 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.
PMID: 34078259DERIVEDAhmed 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.
PMID: 30845917DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no Primary or Secondary Outcome Measures specified in the protocol.
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
July 23, 2012
Primary Completion
October 12, 2016
Study Completion
October 12, 2016
Last Updated
November 9, 2018
Results First Posted
November 9, 2018
Record last verified: 2018-04