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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686581
• Other study ID #: MAF/AGN/NS/CM/002
• Status: Completed
• Start date: July 23, 2012
• Est. completion date: October 12, 2016

Study information

• Verified date: April 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: October 12, 2016
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered according to physician prescription.

Locations

Country	Name	City	State
Germany	Nicole Strickling	Aachen
Germany	Manfred Oberling	Bad Camberg
Germany	Kathrin Krome	Bamberg
Germany	Heike Förster	Baunatal
Germany	Andreas Kupsch	Berlin
Germany	Christoph Engelmann	Berlin
Germany	MVZ Schmerzzentrum Berlin	Berlin
Germany	Hans-Dieter Zug	Böblingen
Germany	Andreas Schwittay	Böhlen
Germany	Bezirksklinikum Mainkofen	Deggendorf
Germany	Michael Kiszka	Erfurt
Germany	Ulrike Kirchhöfer	Erfurt
Germany	Astrid Gendolla	Essen
Germany	Jürgen Hamacher	Essen
Germany	Schmerzzentrum Rhein Main in Frankfurt	Frankfurt
Germany	Bernhard Hellwig	Freiburg
Germany	Peter Asmus	Geldern
Germany	G. Müller-Schwefe	Göppingen
Germany	Borries Kukowski	Göttingen
Germany	Hanno Jaeger	Hamburg
Germany	Veit Becker	Hamburg
Germany	Klaus Gerlach	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Ulrike Köhler	Heidelberg
Germany	Frank Halbgewachs	Heidenheim
Germany	Dirk Buschmann	Herford
Germany	Rotes Kreuz Krankenhaus Kassel	Kassel
Germany	Schmerzklinik Kiel	Kiel
Germany	Migräne-Klinik Königstein	Königstein
Germany	Neuroscience Center Leipzig	Leipzig
Germany	Dietmar Walter Noack	Limburgerhof
Germany	Lothar Klimpel	Limburgerhof
Germany	St.-Marien-Hospital GmbH	Lünen
Germany	Olaf Günther	Magdeburg
Germany	Institut für Forschung und Prävention	Mainz
Germany	Stephan Nautscher-Timmermann	Mühlhausen
Germany	Klinikum der Universität München - Großhadern, Neurologische Klinik	München
Germany	Matthias Haslbeck	München
Germany	Neurologie und Kopfschmerzzentrum Münchner Freiheit	München
Germany	Praxis für Neurologie und SchmerzMedizin	München
Germany	Schmerztherapiezentrum Münster	Münster
Germany	Dr. Becker Rhein-Sieg-Klinik	Nümbrecht
Germany	Roland Leger	Nürnberg
Germany	Matthias Röder	Oberhausen
Germany	mediPlan Klinik GmbH	Ostfildern
Germany	Frank Freitag	Potsdam
Germany	Universität Rostock, Klinik für Neurologie	Rostock
Germany	Ingo Palutke	Stadtroda
Germany	Heinz Peter Herbst	Stuttgart
Germany	Anselm Kornhuber	Ulm
Germany	Universitätsklinikum Ulm, Klinik für Neurologie	Ulm
Germany	Volker Heinicke	Weimar
Germany	Parkinson-Klinik Wolfach	Wolfach
Germany	Michaela Krause	Wolfratshausen
Germany	Jochen Ulzheimer	Würzburg
Germany	Dorothea Händel	Zwickau
Italy	Ospedale Careggi	Firenze
Italy	Istituto Neurologico Carlo Besta di Milano	Milano
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Norway	Hodeverket Headache Clinic	Sandnes
Russian Federation	LLC Neyroklinika	Khabarovsk
Russian Federation	LLC Center for Interdisciplinary Dentistry and Neurology	Moscow
Russian Federation	LLC Clinic Sesil +	Moscow
Russian Federation	LLC University Headache Clinic	Moscow
Russian Federation	LLC Sibneuromed	Novosibirsk
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Santiago de Compostela	Santiago de Compostela
Spain	Hospital Galdácano	Usansolo
Sweden	Löfvingkliniken	Göteborg
Sweden	Centralsjukhuset i Karlstad	Karlstad
Sweden	Läkarhuset Utsikten	Stockholm
United Kingdom	Spire Hull and East Riding Hospital	Anlaby
United Kingdom	University Hospital of North Staffordshire, Neurology Research Unit	Stoke on Trent
United Kingdom	Mid Yorkshire NHS Trust	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Germany,  Italy,  Norway,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]