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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00156910
First received: September 7, 2005
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change in Frequency of Headache Episodes [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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:
  • Change in Frequency of Headache Days [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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

  • Change in Frequency of Acute Headache Pain Medication Intakes [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change in Frequency of Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change in Frequency of Migraine/Probable Migraine Headache Episodes [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 679
Study Start Date: February 2006
Study Completion Date: July 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156910

Locations
United States, Washington
Seattle, Washington, United States
Canada, Ontario
Markham, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Chair: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00156910     History of Changes
Other Study ID Numbers: 191622-079
Study First Received: September 7, 2005
Results First Received: November 5, 2010
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014