Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Drug | Botulinum toxin Type A (BOTOX®) administered according to physician prescription. |
|
| 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] |
| 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. |
Not provided
Inclusion Criteria:
- Prescribed BOTOX® for the prophylaxis of headaches.
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with chronic migraine prescribed BOTOX® for the prophylaxis of headaches
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicole Strickling | Aachen | 52062 | Germany | |||
| Manfred Oberling |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40329224 | Derived | 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. | |
| 34078259 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
| 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] |
| Bad Camberg |
| 65520 |
| Germany |
| Kathrin Krome | Bamberg | 96052 | Germany |
| Heike Förster | Baunatal | 34225 | Germany |
| MVZ Schmerzzentrum Berlin | Berlin | 10435 | Germany |
| Christoph Engelmann | Berlin | 12099 | Germany |
| Andreas Kupsch | Berlin | 14052 | Germany |
| Hans-Dieter Zug | Böblingen | 90489 | Germany |
| Andreas Schwittay | Böhlen | 04564 | Germany |
| Bezirksklinikum Mainkofen | Deggendorf | 94469 | Germany |
| Ulrike Kirchhöfer | Erfurt | 48143 | Germany |
| Michael Kiszka | Erfurt | 99084 | Germany |
| Astrid Gendolla | Essen | 45133 | Germany |
| Jürgen Hamacher | Essen | 45219 | Germany |
| Schmerzzentrum Rhein Main in Frankfurt | Frankfurt | 60313 | Germany |
| Bernhard Hellwig | Freiburg im Breisgau | 79098 | Germany |
| G. Müller-Schwefe | Göppingen | 73033 | Germany |
| Borries Kukowski | Göttingen | 37073 | Germany |
| Peter Asmus | Guelders | 47608 | Germany |
| Veit Becker | Hamburg | 20249 | Germany |
| Hanno Jaeger | Hamburg | 22767 | Germany |
| Klaus Gerlach | Hanover | 30167 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Ulrike Köhler | Heidelberg | 69115 | Germany |
| Frank Halbgewachs | Heidenheim | 89518 | Germany |
| Dirk Buschmann | Herford | 32049 | Germany |
| Rotes Kreuz Krankenhaus Kassel | Kassel | 34121 | Germany |
| Schmerzklinik Kiel | Kiel | 24149 | Germany |
| Migräne-Klinik Königstein | Königstein | 61462 | Germany |
| Neuroscience Center Leipzig | Leipzig | 04275 | Germany |
| Dietmar Walter Noack | Limburgerhof | 67117 | Germany |
| Lothar Klimpel | Limburgerhof | 67117 | Germany |
| St.-Marien-Hospital GmbH | Lünen | 44534 | Germany |
| Olaf Günther | Magdeburg | 39116 | Germany |
| Institut für Forschung und Prävention | Mainz | 55116 | Germany |
| Stephan Nautscher-Timmermann | Mühlhausen | 99974 | Germany |
| Praxis für Neurologie und SchmerzMedizin | München | 80331 | Germany |
| Matthias Haslbeck | München | 80807 | Germany |
| Klinikum der Universität München - Großhadern, Neurologische Klinik | München | 81377 | Germany |
| Neurologie und Kopfschmerzzentrum Münchner Freiheit | München | 81667 | Germany |
| Schmerztherapiezentrum Münster | Münster | 48143 | Germany |
| Roland Leger | Nuremberg | 90489 | Germany |
| Dr. Becker Rhein-Sieg-Klinik | Nümbrecht | 51588 | Germany |
| Matthias Röder | Oberhausen | 46145 | Germany |
| mediPlan Klinik GmbH | Ostfildern | 73760 | Germany |
| Frank Freitag | Potsdam | 14467 | Germany |
| Universität Rostock, Klinik für Neurologie | Rostock | 18147 | Germany |
| Ingo Palutke | Stadtroda | 07646 | Germany |
| Heinz Peter Herbst | Stuttgart | 70718 | Germany |
| Anselm Kornhuber | Ulm | 89073 | Germany |
| Universitätsklinikum Ulm, Klinik für Neurologie | Ulm | 89081 | Germany |
| Volker Heinicke | Weimar | 99423 | Germany |
| Parkinson-Klinik Wolfach | Wolfach | 77709 | Germany |
| Michaela Krause | Wolfratshausen | 82515 | Germany |
| Jochen Ulzheimer | Würzburg | 97074 | Germany |
| Dorothea Händel | Zwickau | 80560 | Germany |
| Ospedale Careggi | Florence | 50139 | Italy |
| Istituto Neurologico Carlo Besta di Milano | Milan | 20133 | Italy |
| Azienda Ospedaliera Sant'Andrea | Roma | 00189 | Italy |
| Hodeverket Headache Clinic | Sandnes | 4319 | Norway |
| LLC Neyroklinika | Khabarovsk | 680000 | Russia |
| LLC Center for Interdisciplinary Dentistry and Neurology | Moscow | 119146 | Russia |
| LLC Clinic Sesil + | Moscow | 125047 | Russia |
| LLC University Headache Clinic | Moscow | 129090 | Russia |
| LLC Sibneuromed | Novosibirsk | 630091 | Russia |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Reina SofÃa | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Central de Asturias | Oviedo | 33006 | Spain |
| Hospital Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Galdácano | Usansolo | 48960 | Spain |
| Löfvingkliniken | Gothenburg | 41120 | Sweden |
| Centralsjukhuset i Karlstad | Karlstad | 65230 | Sweden |
| Läkarhuset Utsikten | Stockholm | 11628 | Sweden |
| Spire Hull and East Riding Hospital | Anlaby | HU10 7AZ | United Kingdom |
| University Hospital of North Staffordshire, Neurology Research Unit | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Mid Yorkshire NHS Trust | Wakefield | WF1 4DG | United Kingdom |
| 30845917 | Derived | 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. |
| Safety Analysis Set; Received Study Drug |
|
| Completed 24 Months |
|
| COMPLETED | Completed=Completed Treatment |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who received at least one dose of BOTOX®.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point. | Posted | Number | percentage of participants | 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, who were hospitalized. | Posted | Mean | Standard Deviation | days | 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point. | Posted | Number | percentage of participants | 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. | Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point. | Posted | Median | Full Range | score on a scale | 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. | Participant from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point. | Posted | Median | Full Range | score on a scale | 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point. | Posted | Median | Full Range | score on a scale | 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point. | Posted | Median | Full Range | days | 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. | Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available. | Posted | Number | percentage of participants | ADM last [median 20.30 months] |
|
|
First dose of study drug to FU last [median 21.20 months]
As per the protocol, Adverse Drug Reactions and Serious Adverse Drug Reactions were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOTOX® | BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician. | 0 | 633 | 8 | 633 | 34 | 633 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
| |
| Psychosomatic disease | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid ptosis | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
There were no Primary or Secondary Outcome Measures specified in the protocol.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|