- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168428
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
October 24, 2013 updated by: Allergan
This is a 60 week study including a double-blind phase followed by an open-label phase.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
705
Phase
- Phase 3
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
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Alberta
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Calgary, Alberta, Canada
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Zagreb, Croatia
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Essen, Germany
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Zurich, Switzerland
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London, United Kingdom
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California
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Walnut Creek, California, United States
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Frequent migraine (>=15 headache days per month)
- >=4 distinct headache episodes lasting >=4 hours
- >=50% of baseline headache days migraine/probable migraine days
Exclusion Criteria:
- Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
- Any medical condition that puts the patient at increased risk with exposure to BOTOX
- Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
- Use of prophylactic headache medication within 28 days prior to week -4
- Unremitting headache lasting continuously throughout the 4-week baseline period
- Known or suspected TMD
- Diagnosis of fibromyalgia
- Beck depression inventory score >24 at week-4
- Psychiatric problems that may have interfered with study participation
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: botulinum toxin Type A
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase.
Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
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Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase.
Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
Other Names:
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Placebo Comparator: Placebo (saline)
Two treatment sessions in the double-blind phase.
Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
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Two treatment sessions in the double-blind phase.
Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Frequency of Headache Days
Time Frame: Baseline, Week 24
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Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24.
Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.
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Baseline, Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Frequency of Headache Episodes
Time Frame: Baseline, Week 24
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Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24.
Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.
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Baseline, Week 24
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Change in Total Cumulative Hours of Headache Occurring on Headache Days
Time Frame: Baseline, Week 24
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Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24.
Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.
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Baseline, Week 24
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Change in Frequency of Moderate/Severe Headache Days
Time Frame: Baseline, Week 24
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Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24.
Those calendar days with >= 4 continuous hours of headache were selected.
As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.
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Baseline, Week 24
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Change in Frequency of Migraine/Probable Migraine Headache Days
Time Frame: Baseline, Week 24
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Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24.
Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.
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Baseline, Week 24
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Percentage of Patients With Severe HIT-6 Impact Category Scores
Time Frame: Week 24
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Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24.
The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being.
Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always.
The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).
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Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Diener HC, Dodick DW, Lipton RB, Manack Adams A, DeGryse RE, Silberstein SD. Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis. Pain Ther. 2020 Dec;9(2):683-694. doi: 10.1007/s40122-020-00198-w. Epub 2020 Oct 7.
- Silberstein SD, Diener HC, Dodick DW, Manack Adams A, DeGryse RE, Lipton RB. The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine. Pain Ther. 2020 Dec;9(2):695-707. doi: 10.1007/s40122-020-00199-9. Epub 2020 Oct 7.
- Dodick DW, Silberstein SD, Lipton RB, DeGryse RE, Adams AM, Diener HC. Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data. Cephalalgia. 2019 Jul;39(8):945-956. doi: 10.1177/0333102418825382. Epub 2019 May 21.
- Silberstein SD, Dodick DW, Aurora SK, Diener HC, DeGryse RE, Lipton RB, Turkel CC. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015 Sep;86(9):996-1001. doi: 10.1136/jnnp-2013-307149. Epub 2014 Dec 12.
- Rendas-Baum R, Yang M, Varon SF, Bloudek LM, DeGryse RE, Kosinski M. Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine. Health Qual Life Outcomes. 2014 Aug 1;12:117. doi: 10.1186/s12955-014-0117-0.
- Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.
- Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.
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
March 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 18, 2013
Last Update Submitted That Met QC Criteria
October 24, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 191622-080
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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