A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
1 other identifier
interventional
705
6 countries
6
Brief Summary
This is a 60 week study including a double-blind phase followed by an open-label phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
December 7, 2010
CompletedNovember 18, 2013
October 1, 2013
1.8 years
September 12, 2005
November 5, 2010
October 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Frequency of Headache Days
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.
Baseline, Week 24
Secondary Outcomes (5)
Change in Total Cumulative Hours of Headache Occurring on Headache Days
Baseline, Week 24
Change in Frequency of Moderate/Severe Headache Days
Baseline, Week 24
Change in Frequency of Migraine/Probable Migraine Headache Days
Baseline, Week 24
Change in Frequency of Headache Episodes
Baseline, Week 24
Percentage of Patients With Severe HIT-6 Impact Category Scores
Week 24
Study Arms (2)
botulinum toxin Type A
EXPERIMENTALTwo 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.
Placebo (saline)
PLACEBO COMPARATORTwo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Frequent migraine (\>=15 headache days per month)
- \>=4 distinct headache episodes lasting \>=4 hours
- \>=50% of baseline headache days migraine/probable migraine days
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (6)
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Zagreb, Croatia
Unknown Facility
Essen, Germany
Unknown Facility
Zurich, Switzerland
Unknown Facility
London, United Kingdom
Related Publications (7)
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.
PMID: 33026631DERIVEDSilberstein 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.
PMID: 33026630DERIVEDDodick 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.
PMID: 31112399DERIVEDSilberstein 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.
PMID: 25500317DERIVEDRendas-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.
PMID: 25080874DERIVEDAurora 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.
PMID: 21883197DERIVEDDodick 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.
PMID: 20487038DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
August 1, 2008
Last Updated
November 18, 2013
Results First Posted
December 7, 2010
Record last verified: 2013-10