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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: botulinum toxin Type A

• Study Type: Observational
• Enrollment (Actual): 641

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52062
    • Nicole Strickling
  • Bad Camberg, Germany, 65520
    • Manfred Oberling
  • Bamberg, Germany, 96052
    • Kathrin Krome
  • Baunatal, Germany, 34225
    • Heike Förster
  • Berlin, Germany, 10435
    • MVZ Schmerzzentrum Berlin
  • Berlin, Germany, 12099
    • Christoph Engelmann
  • Berlin, Germany, 14052
    • Andreas Kupsch
  • Böblingen, Germany, 90489
    • Hans-Dieter Zug
  • Böhlen, Germany, 04564
    • Andreas Schwittay
  • Deggendorf, Germany, 94469
    • Bezirksklinikum Mainkofen
  • Erfurt, Germany, 48143
    • Ulrike Kirchhöfer
  • Erfurt, Germany, 99084
    • Michael Kiszka
  • Essen, Germany, 45133
    • Astrid Gendolla
  • Essen, Germany, 45219
    • Jürgen Hamacher
  • Frankfurt, Germany, 60313
    • Schmerzzentrum Rhein Main in Frankfurt
  • Freiburg, Germany, 79098
    • Bernhard Hellwig
  • Geldern, Germany, 47608
    • Peter Asmus
  • Göppingen, Germany, 73033
    • G. Müller-Schwefe
  • Göttingen, Germany, 37073
    • Borries Kukowski
  • Hamburg, Germany, 20249
    • Veit Becker
  • Hamburg, Germany, 22767
    • Hanno Jaeger
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany, 30167
    • Klaus Gerlach
  • Heidelberg, Germany, 69115
    • Ulrike Köhler
  • Heidenheim, Germany, 89518
    • Frank Halbgewachs
  • Herford, Germany, 32049
    • Dirk Buschmann
  • Kassel, Germany, 34121
    • Rotes Kreuz Krankenhaus Kassel
  • Kiel, Germany, 24149
    • Schmerzklinik Kiel
  • Königstein, Germany, 61462
    • Migräne-Klinik Königstein
  • Leipzig, Germany, 04275
    • Neuroscience Center Leipzig
  • Limburgerhof, Germany, 67117
    • Dietmar Walter Noack
  • Limburgerhof, Germany, 67117
    • Lothar Klimpel
  • Lünen, Germany, 44534
    • St.-Marien-Hospital GmbH
  • Magdeburg, Germany, 39116
    • Olaf Günther
  • Mainz, Germany, 55116
    • Institut für Forschung und Prävention
  • Mühlhausen, Germany, 99974
    • Stephan Nautscher-Timmermann
  • München, Germany, 80331
    • Praxis für Neurologie und SchmerzMedizin
  • München, Germany, 80807
    • Matthias Haslbeck
  • München, Germany, 81377
    • Klinikum der Universität München - Großhadern, Neurologische Klinik
  • München, Germany, 81667
    • Neurologie und Kopfschmerzzentrum Münchner Freiheit
  • Münster, Germany, 48143
    • Schmerztherapiezentrum Münster
  • Nümbrecht, Germany, 51588
    • Dr. Becker Rhein-Sieg-Klinik
  • Nürnberg, Germany, 90489
    • Roland Leger
  • Oberhausen, Germany, 46145
    • Matthias Röder
  • Ostfildern, Germany, 73760
    • mediPlan Klinik GmbH
  • Potsdam, Germany, 14467
    • Frank Freitag
  • Rostock, Germany, 18147
    • Universität Rostock, Klinik für Neurologie
  • Stadtroda, Germany, 07646
    • Ingo Palutke
  • Stuttgart, Germany, 70718
    • Heinz Peter Herbst
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm, Klinik für Neurologie
  • Ulm, Germany, 89073
    • Anselm Kornhuber
  • Weimar, Germany, 99423
    • Volker Heinicke
  • Wolfach, Germany, 77709
    • Parkinson-Klinik Wolfach
  • Wolfratshausen, Germany, 82515
    • Michaela Krause
  • Würzburg, Germany, 97074
    • Jochen Ulzheimer
  • Zwickau, Germany, 80560
    • Dorothea Händel
• Italy
  • Firenze, Italy, 50139
    • Ospedale Careggi
  • Milano, Italy, 20133
    • Istituto Neurologico Carlo Besta di Milano
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant'Andrea
• Norway
  • Sandnes, Norway, 4319
    • Hodeverket Headache Clinic
• Russian Federation
  • Khabarovsk, Russian Federation, 680000
    • LLC Neyroklinika
  • Moscow, Russian Federation, 119146
    • LLC Center for Interdisciplinary Dentistry and Neurology
  • Moscow, Russian Federation, 125047
    • LLC Clinic Sesil +
  • Moscow, Russian Federation, 129090
    • LLC University Headache Clinic
  • Novosibirsk, Russian Federation, 630091
    • LLC Sibneuromed
• Spain
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Oviedo, Spain, 33006
    • Hospital Central de Asturias
  • Santiago de Compostela, Spain, 15706
    • Hospital Santiago de Compostela
  • Usansolo, Spain, 48960
    • Hospital Galdácano
• Sweden
  • Göteborg, Sweden, 41120
    • Löfvingkliniken
  • Karlstad, Sweden, 65230
    • Centralsjukhuset i Karlstad
  • Stockholm, Sweden, 11628
    • Läkarhuset Utsikten
• United Kingdom
  • Anlaby, United Kingdom, HU10 7AZ
    • Spire Hull and East Riding Hospital
  • Stoke on Trent, United Kingdom, ST4 6QG
    • University Hospital of North Staffordshire, Neurology Research Unit
  • Wakefield, United Kingdom, WF1 4DG
    • Mid Yorkshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic migraine prescribed BOTOX® for the prophylaxis of headaches

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BOTOX®; BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.	Drug: botulinum toxin Type A; Botulinum toxin Type A (BOTOX®) administered according to physician prescription.; Other Names: BOTOX®; onabotulinumtoxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score	The MSQ is a 14-item questionnaire to measure health-related quality-of-life attributed to migraine in the past 4 weeks. Each item is scored on a 6-point scale where: 1=none of the time to 6=all of the time. There are 3 dimensions: Role-function Restrictive (questions 1 to 7; score range 7 to 42), Role-function Preventive (questions 8 to 11; score range 4 to 24) and Emotional-function (questions 12 to 14; score range 3 to 18). The individual dimension scores were converted to a score of 0 to 100; the total score ranged from 0 to 300 with higher numbers representing a better quality of life. A positive change from baseline in the dimension scores and the total score indicates that quality of life has improved.	Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]
Change From Baseline in the EQ-5D Questionnaire Total Score	The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) assessed by the participant using a 3-point scale: 1=no problems, 2=some problems and 3=extreme problems. The combination of levels from the 5 dimensions results in a health state code. The total score is calculated by converting the health state code into a score: start with score 1.000=[11111] (perfect health state), subtract 0.081 (constant) for any other state, subtract nothing for level 1 on any dimension, subtract appropriate level 2 or level 3 value for each dimension from a table of constants [Level 2: Mobility 0.069, Self-care 0.104, Usual activity 0.036, Pain/discomfort 0.123, Anxiety/depression 0.071] [Level 3: Mobility 0.314, Self-care 0.214, Usual activity 0.094, Pain/discomfort 0.386, Anxiety/depression 0.236], subtract 0.269 if any dimension has a level 3 problem. Higher numbers indicate better health. A positive change from Baseline indicates improvement.	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	The EQ-5D health state scale is a visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better state of health. Participants were asked to rate their health state on a drawn line that started at 0 and ended at 100. A positive change from baseline in the health state score indicates that the participant's health state has improved.	Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
Change From Baseline in the Number of Headache Days	At each visit, participants were asked to provide the number of headache days he/she experienced in the last month. A headache day was defined as 4 or more hours of continuous headache. A negative change from Baseline (less headache days) indicates improvement.	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	At each visit, participants and physicians were asked to indicate the level of satisfaction that he/she had with the treatment. Physicians indicated the level of satisfaction with the patient's treatment. The 4- point scale consisted of the following responses: insufficient, moderate, good and very good. The combined percentage of "good" and "very good" responses by participants and physicians are reported.	ADM last [median 20.30 months]

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2012
• Primary Completion (Actual): October 12, 2016
• Study Completion (Actual): October 12, 2016

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MAF/AGN/NS/CM/002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No