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

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168428
• Other study ID #: 191622-080
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 24, 2013
• Start date: March 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Germany,  Switzerland,  United Kingdom, 

Outcome

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