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

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Biological: Botulinum Toxin Type A; Other: placebo (saline)

• Registration Number: NCT00168428
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Study Start: 2006-03
• Primary Completion: 2007-12
• Study Completion: 2008-08
• Disposition First Submitted: 2009-06-17
• Disposition First Submitted QC: 2009-09-25
• Disposition First Posted: 2009-09-28
• Results First Submitted: 2010-11-05
• Results First Submitted QC: 2010-11-05
• Results First Posted: 2010-12-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A	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.
Placebo (saline)	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.

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Headache Days	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.

Secondary Outcome Measures

Name	Time	Method
Change in Frequency of Migraine/Probable Migraine Headache Days	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 the ICHD-II criteria for migraine or probable migraine.
Change in Total Cumulative Hours of Headache Occurring on Headache Days	Baseline, Week 24	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 Headache Episodes	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.
Change in Frequency of Moderate/Severe Headache Days	Baseline, Week 24	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.
Percentage of Patients With Severe HIT-6 Impact Category Scores	Week 24	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).