Clinical trial NCT00168428: A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 60 week study including a double-blind phase followed by an open-label phase.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Frequency of Headache Days
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change in Total Cumulative Hours of Headache Occurring on Headache Days
timeFrame: Baseline, Week 24
measure: Change in Frequency of Moderate/Severe Headache Days
timeFrame: Baseline, Week 24
measure: Change in Frequency of Migraine/Probable Migraine Headache Days
timeFrame: Baseline, Week 24
measure: Change in Frequency of Headache Episodes
timeFrame: Baseline, Week 24
measure: Percentage of Patients With Severe HIT-6 Impact Category Scores
timeFrame: Week 24
Other outcomes:
Locations:
city: Walnut Creek
country: United States
state: California
city: Calgary
country: Canada
state: Alberta
city: Zagreb
country: Croatia
city: Essen
country: Germany
city: Zurich
country: Switzerland
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.