Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01686581
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment
Migraine Disorders Drug: botulinum toxin Type A

Layout table for study information
Study Type : Observational
Actual Enrollment : 641 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 23, 2012
Actual Primary Completion Date : October 12, 2016
Actual Study Completion Date : October 12, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic migraine prescribed BOTOX® for the prophylaxis of headaches
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686581


  Show 77 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01686581     History of Changes
Other Study ID Numbers: MAF/AGN/NS/CM/002
First Posted: September 18, 2012    Key Record Dates
Results First Posted: November 9, 2018
Last Update Posted: November 9, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents