Clinical trial NCT01686581: An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic migraine prescribed BOTOX® for the prophylaxis of headaches

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Admitted to the Hospital for Headache
timeFrame: Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]
measure: Mean Number of Days of Headache-related Hospital Admissions
timeFrame: Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]
measure: Percentage of Participants Who Visited Any Healthcare Professional (HCP)
timeFrame: Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]
Secondary outcomes:
measure: Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
timeFrame: Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]
measure: Change From Baseline in the EQ-5D Questionnaire Total Score
timeFrame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
measure: Change From Baseline in the Health State Score of the EQ-5D Questionnaire
timeFrame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
measure: Change From Baseline in the Number of Headache Days
timeFrame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
measure: Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale
timeFrame: ADM last [median 20.30 months]
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Nicole Strickling
city: Bad Camberg
country: Germany
facility: Manfred Oberling
city: Bamberg
country: Germany
facility: Kathrin Krome
city: Baunatal
country: Germany
facility: Heike Förster
city: Berlin
country: Germany
facility: MVZ Schmerzzentrum Berlin
city: Berlin
country: Germany
facility: Christoph Engelmann
city: Berlin
country: Germany
facility: Andreas Kupsch
city: Böblingen
country: Germany
facility: Hans-Dieter Zug
city: Böhlen
country: Germany
facility: Andreas Schwittay
city: Deggendorf
country: Germany
facility: Bezirksklinikum Mainkofen
city: Erfurt
country: Germany
facility: Ulrike Kirchhöfer
city: Erfurt
country: Germany
facility: Michael Kiszka
city: Essen
country: Germany
facility: Astrid Gendolla
city: Essen
country: Germany
facility: Jürgen Hamacher
city: Frankfurt
country: Germany
facility: Schmerzzentrum Rhein Main in Frankfurt
city: Freiburg
country: Germany
facility: Bernhard Hellwig
city: Geldern
country: Germany
facility: Peter Asmus
city: Göppingen
country: Germany
facility: G. Müller-Schwefe
city: Göttingen
country: Germany
facility: Borries Kukowski
city: Hamburg
country: Germany
facility: Veit Becker
city: Hamburg
country: Germany
facility: Hanno Jaeger
city: Hannover
country: Germany
facility: Klaus Gerlach
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Ulrike Köhler
city: Heidenheim
country: Germany
facility: Frank Halbgewachs
city: Herford
country: Germany
facility: Dirk Buschmann
city: Kassel
country: Germany
facility: Rotes Kreuz Krankenhaus Kassel
city: Kiel
country: Germany
facility: Schmerzklinik Kiel
city: Königstein
country: Germany
facility: Migräne-Klinik Königstein
city: Leipzig
country: Germany
facility: Neuroscience Center Leipzig
city: Limburgerhof
country: Germany
facility: Dietmar Walter Noack
city: Limburgerhof
country: Germany
facility: Lothar Klimpel
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Magdeburg
country: Germany
facility: Olaf Günther
city: Mainz
country: Germany
facility: Institut für Forschung und Prävention
city: Mühlhausen
country: Germany
facility: Stephan Nautscher-Timmermann
city: München
country: Germany
facility: Praxis für Neurologie und SchmerzMedizin
city: München
country: Germany
facility: Matthias Haslbeck
city: München
country: Germany
facility: Klinikum der Universität München - Großhadern, Neurologische Klinik
city: München
country: Germany
facility: Neurologie und Kopfschmerzzentrum Münchner Freiheit
city: Münster
country: Germany
facility: Schmerztherapiezentrum Münster
city: Nümbrecht
country: Germany
facility: Dr. Becker Rhein-Sieg-Klinik
city: Nürnberg
country: Germany
facility: Roland Leger
city: Oberhausen
country: Germany
facility: Matthias Röder
city: Ostfildern
country: Germany
facility: mediPlan Klinik GmbH
city: Potsdam
country: Germany
facility: Frank Freitag
city: Rostock
country: Germany
facility: Universität Rostock, Klinik für Neurologie
city: Stadtroda
country: Germany
facility: Ingo Palutke
city: Stuttgart
country: Germany
facility: Heinz Peter Herbst
city: Ulm
country: Germany
facility: Anselm Kornhuber
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Klinik für Neurologie
city: Weimar
country: Germany
facility: Volker Heinicke
city: Wolfach
country: Germany
facility: Parkinson-Klinik Wolfach
city: Wolfratshausen
country: Germany
facility: Michaela Krause
city: Würzburg
country: Germany
facility: Jochen Ulzheimer
city: Zwickau
country: Germany
facility: Dorothea Händel
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Milano
country: Italy
facility: Istituto Neurologico Carlo Besta di Milano
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Sandnes
country: Norway
facility: Hodeverket Headache Clinic
city: Khabarovsk
country: Russian Federation
facility: LLC Neyroklinika
city: Moscow
country: Russian Federation
facility: LLC Center for Interdisciplinary Dentistry and Neurology
city: Moscow
country: Russian Federation
facility: LLC Clinic Sesil +
city: Moscow
country: Russian Federation
facility: LLC University Headache Clinic
city: Novosibirsk
country: Russian Federation
facility: LLC Sibneuromed
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hospital Santiago de Compostela
city: Usansolo
country: Spain
facility: Hospital Galdácano
city: Göteborg
country: Sweden
facility: Löfvingkliniken
city: Karlstad
country: Sweden
facility: Centralsjukhuset i Karlstad
city: Stockholm
country: Sweden
facility: Läkarhuset Utsikten
city: Anlaby
country: United Kingdom
facility: Spire Hull and East Riding Hospital
city: Stoke on Trent
country: United Kingdom
facility: University Hospital of North Staffordshire, Neurology Research Unit
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire NHS Trust
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.