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

April 6, 2018 updated by: Allergan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
641

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Sofia
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]
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)
Time Frame: Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Time Frame: Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]
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
Time Frame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
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
Time Frame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
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
Time Frame: Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]
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
Time Frame: ADM last [median 20.30 months]
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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