Migraine Disorders Clinical Trial
Verified date | October 2013 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a 60 week study including a double-blind phase followed by an open-label phase.
Status | Completed |
Enrollment | 705 |
Est. completion date | August 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States, Canada, Croatia, Germany, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Week 24 | No |
Secondary | 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. | Baseline, Week 24 | No |
Secondary | 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. | Baseline, Week 24 | No |
Secondary | 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. | Baseline, Week 24 | No |
Secondary | 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. | Baseline, Week 24 | No |
Secondary | Percentage of Patients With Severe HIT-6 Impact Category Scores | 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). | Week 24 | No |
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