20
Participants
Start Date
October 31, 2012
Primary Completion Date
August 31, 2014
Study Completion Date
August 31, 2014
onabotulinumtoxinA
All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
Topiramate
"Subjects randomized to the onabotulinumtoxinA + topiramate group will receive:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period."
Placebo
"Subjects randomized to the onabotulinumtoxinA + placebo group will receive:~Week 1: placebo 25 mg qhs Week 2: placebo 25 mg bid Week 3: placebo 25 mg q am + placebo 50 mg qhs Week 4: placebo 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period."
Clinvest/A Division of Banyan Group, Inc., Springfield
Collaborators (1)
Allergan
INDUSTRY
Cady, Roger, M.D.
INDIV