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

PHASE3CompletedINTERVENTIONAL
Enrollment

705

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

August 31, 2008

Conditions
Migraine Disorders
Interventions
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.

Trial Locations (6)

Unknown

Walnut Creek

Calgary

Zagreb

Essen

Zurich

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY