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Migraine DisordersNCT01686581

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

An observational study of Migraine Disorders, run by Allergan at 77 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine Disorders
What is being tested?
botulinum toxin Type A
How many people
641 participants
Where
77 sitesin 7 countries
Study dates
23 Jul 2012to 12 Oct 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Prescribed BOTOX® for the prophylaxis of headaches.

Who cannot join

  • 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).

Trial locations and contacts

77 sites in 7 countries.

77 sites in 7 countries

Germany56 sites

  • Nicole Strickling

    Aachen, 52062

  • Manfred Oberling

    Bad Camberg, 65520

  • Kathrin Krome

    Bamberg, 96052

  • Heike Förster

    Baunatal, 34225

  • MVZ Schmerzzentrum Berlin

    Berlin, 10435

  • Christoph Engelmann

    Berlin, 12099

  • Andreas Kupsch

    Berlin, 14052

  • Hans-Dieter Zug

    Böblingen, 90489

  • Andreas Schwittay

    Böhlen, 04564

  • Bezirksklinikum Mainkofen

    Deggendorf, 94469

  • Ulrike Kirchhöfer

    Erfurt, 48143

  • Michael Kiszka

    Erfurt, 99084

  • Astrid Gendolla

    Essen, 45133

  • Jürgen Hamacher

    Essen, 45219

  • Schmerzzentrum Rhein Main in Frankfurt

    Frankfurt, 60313

  • Bernhard Hellwig

    Freiburg im Breisgau, 79098

  • G. Müller-Schwefe

    Göppingen, 73033

  • Borries Kukowski

    Göttingen, 37073

  • Peter Asmus

    Guelders, 47608

  • Veit Becker

    Hamburg, 20249

  • Hanno Jaeger

    Hamburg, 22767

  • Klaus Gerlach

    Hanover, 30167

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Ulrike Köhler

    Heidelberg, 69115

  • Frank Halbgewachs

    Heidenheim, 89518

  • Dirk Buschmann

    Herford, 32049

  • Rotes Kreuz Krankenhaus Kassel

    Kassel, 34121

  • Schmerzklinik Kiel

    Kiel, 24149

  • Migräne-Klinik Königstein

    Königstein, 61462

  • Neuroscience Center Leipzig

    Leipzig, 04275

  • Dietmar Walter Noack

    Limburgerhof, 67117

  • Lothar Klimpel

    Limburgerhof, 67117

  • St.-Marien-Hospital GmbH

    Lünen, 44534

  • Olaf Günther

    Magdeburg, 39116

  • Institut für Forschung und Prävention

    Mainz, 55116

  • Stephan Nautscher-Timmermann

    Mühlhausen, 99974

  • Praxis für Neurologie und SchmerzMedizin

    München, 80331

  • Matthias Haslbeck

    München, 80807

  • Klinikum der Universität München - Großhadern, Neurologische Klinik

    München, 81377

  • Neurologie und Kopfschmerzzentrum Münchner Freiheit

    München, 81667

  • Schmerztherapiezentrum Münster

    Münster, 48143

  • Dr. Becker Rhein-Sieg-Klinik

    Nümbrecht, 51588

  • Roland Leger

    Nuremberg, 90489

  • Matthias Röder

    Oberhausen, 46145

  • mediPlan Klinik GmbH

    Ostfildern, 73760

  • Frank Freitag

    Potsdam, 14467

  • Universität Rostock, Klinik für Neurologie

    Rostock, 18147

  • Ingo Palutke

    Stadtroda, 07646

  • Heinz Peter Herbst

    Stuttgart, 70718

  • Anselm Kornhuber

    Ulm, 89073

  • Universitätsklinikum Ulm, Klinik für Neurologie

    Ulm, 89081

  • Volker Heinicke

    Weimar, 99423

  • Parkinson-Klinik Wolfach

    Wolfach, 77709

  • Michaela Krause

    Wolfratshausen, 82515

  • Jochen Ulzheimer

    Würzburg, 97074

  • Dorothea Händel

    Zwickau, 80560

Other trials in Germany

Spain6 sites

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Central de Asturias

    Oviedo, 33006

  • Hospital Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Galdácano

    Usansolo, 48960

Other trials in Spain

Russia5 sites

  • LLC Neyroklinika

    Khabarovsk, 680000

  • LLC Center for Interdisciplinary Dentistry and Neurology

    Moscow, 119146

  • LLC Clinic Sesil +

    Moscow, 125047

  • LLC University Headache Clinic

    Moscow, 129090

  • LLC Sibneuromed

    Novosibirsk, 630091

Other trials in Russia

Italy3 sites

  • Ospedale Careggi

    Florence, 50139

  • Istituto Neurologico Carlo Besta di Milano

    Milan, 20133

  • Azienda Ospedaliera Sant'Andrea

    Roma, 00189

Other trials in Italy

Sweden3 sites

  • Löfvingkliniken

    Gothenburg, 41120

  • Centralsjukhuset i Karlstad

    Karlstad, 65230

  • Läkarhuset Utsikten

    Stockholm, 11628

Other trials in Sweden

United Kingdom3 sites

  • Spire Hull and East Riding Hospital

    Anlaby, HU10 7AZ

  • University Hospital of North Staffordshire, Neurology Research Unit

    Stoke-on-Trent, ST4 6QG

  • Mid Yorkshire NHS Trust

    Wakefield, WF1 4DG

Other trials in United Kingdom

Norway1 site

  • Hodeverket Headache Clinic

    Sandnes, 4319

Other trials in Norway

About this study

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

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.

Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin Type ADrug

    Also called BOTOX®, onabotulinumtoxin A

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

Study groups in NCT01686581
Study groupRoleWhat they receive
BOTOX®BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
Receives: Drug: botulinum toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]

  2. 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.

    Measured: Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]

  3. 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.

    Measured: Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]

Secondary outcomes (5)

  1. 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.

    Measured: Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]

  2. 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.

    Measured: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]

  3. 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.

    Measured: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]

  4. 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.

    Measured: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]

  5. 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.

    Measured: ADM last [median 20.30 months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2012 (estimated)
  2. Study start23 Jul 2012
  3. Primary completion12 Oct 2016
  4. Study completion12 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01686581
Sponsor's protocol ID
MAF/AGN/NS/CM/002
Status last verified
Apr 2018
First submitted
13 Sep 2012
Last updated
9 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40329224

  • 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.

    PubMed 34078259

  • 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.

    PubMed 30845917

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine Disorders, run by Allergan at 77 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Germany, Spain, Russia, Italy, Sweden and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Admitted to the Hospital for Headache (time frame: Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01686581, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.

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