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:
NCT00168428
First received: September 12, 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 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, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary 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.


Secondary Outcome Measures:
  • Change in Total Cumulative Hours of Headache Occurring on Headache Days [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.

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

  • 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 the ICHD-II criteria for migraine or probable migraine.

  • 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.

  • Percentage of Patients With Severe HIT-6 Impact Category Scores [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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).


Enrollment: 705
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: December 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 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 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: NCT00168428

Locations
United States, California
Walnut Creek, California, United States
Canada, Alberta
Calgary, Alberta, Canada
Croatia
Zagreb, Croatia
Germany
Essen, Germany
Switzerland
Zurich, Switzerland
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: 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: NCT00168428     History of Changes
Other Study ID Numbers: 191622-080
Study First Received: September 12, 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
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014