A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches - Full Text View

Purpose

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

Condition	Intervention	Phase
Migraine Disorders	Biological: Botulinum Toxin Type A Other: Placebo (saline)	Phase III

Genetics Home Reference related topics:

familial hemiplegic migraine

MedlinePlus related topics:

Botox Headache Migraine

ChemIDplus related topics:

Sodium chloride Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Frequency of headache episodes [ Time Frame: Week -4 to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of headache days [ Time Frame: Week -4 to Week 24 ] [ Designated as safety issue: No ]
Frequency of acute headache pain medication use [ Time Frame: Week -4 to Week 24 ] [ Designated as safety issue: No ]
Frequency of migraine/probable migraine days [ Time Frame: Week -4 to Week 24 ] [ Designated as safety issue: No ]
Frequency of migraine/probable migraine headache episodes [ Time Frame: Week -4 to Week 24 ] [ Designated as safety issue: No ]

Enrollment:	679
Study Start Date:	February 2006
Study Completion Date:	July 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Botulinum Toxin Type A	Biological: 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.
2: Placebo Comparator Placebo (saline)	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 Temporomandibular Disorders (TMD)
Diagnosis of fibromyalgia
Beck depression inventory score >24 at week-4
Psychiatric problems that may have interfered with study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156910

Locations


United States, Washington

	Seattle, Washington, United States

Canada, Ontario

	Markham, Ontario, Canada

Sponsors and Collaborators

Allergan

Investigators


Study Chair:	Medical Director	Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-079
First Received:	September 7, 2005
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00156910
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Botulinum Toxins

Migraine Disorders

Headache

Central Nervous System Diseases

Headache Disorders, Primary

Botulinum Toxin Type A

Brain Diseases

Headache Disorders

Additional relevant MeSH terms:

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Neuromuscular Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00156910