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A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

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ClinicalTrials.gov Identifier: NCT00156910
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 7, 2010
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This is a 60 week study including a double-blind phase followed by an open-label extension phase.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: Botulinum Toxin Type A Other: Placebo (saline) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 679 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: 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.
Other Name: BOTOX®
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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Frequency of Headache Episodes [ Time Frame: Baseline, Week 24 ]
    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.


Secondary Outcome Measures :
  1. Change in Frequency of Headache Days [ Time Frame: Baseline, Week 24 ]
    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

  2. Change in Frequency of Acute Headache Pain Medication Intakes [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.

  3. Change in Frequency of Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Week 24 ]
    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 ICHD-II criteria for migraine or probable migraine.

  4. Change in Frequency of Migraine/Probable Migraine Headache Episodes [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in frequency (number) of migraine/probable migraine 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 and met ICHD-II criteria for migraine or probable migraine.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Temporomandibular Disorders (TMD)
  • Diagnosis of fibromyalgia
  • Beck depression inventory score >24 at week-4
  • Psychiatric problems that may have interfered with study participation
Contacts and Locations
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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): NCT00156910


Locations
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United States, Washington
Seattle, Washington, United States
Canada, Ontario
Markham, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
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Study Chair: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00156910    
Other Study ID Numbers: 191622-079
First Posted: September 12, 2005    Key Record Dates
Results First Posted: December 7, 2010
Last Update Posted: November 18, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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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