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

Phase 3CompletedNCT00168428

Allergan705 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

705

Conditions

Migraine Disorders

Interventions

Botulinum Toxin Type ABIOLOGICAL

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.

placebo (saline)OTHER

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Walnut Creek, California, United States

Unnamed facility

Calgary, Alberta, Canada

Unnamed facility

Zagreb, Croatia

Unnamed facility

Essen, Germany

Unnamed facility

Zurich, Switzerland

Outcomes

Primary Outcomes

Change in Frequency of Headache Days

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.

Time frame: Baseline, Week 24

Secondary Outcomes

Change in Total Cumulative Hours of Headache Occurring on Headache Days

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.

Time frame: Baseline, Week 24

Change in Frequency of Moderate/Severe Headache Days

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.

Time frame: Baseline, Week 24

Change in Frequency of Migraine/Probable Migraine Headache Days

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.

Time frame: Baseline, Week 24

Change in Frequency of Headache Episodes

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.

Data from ClinicalTrials.gov

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