A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Chronic Migraine
Interventions
DRUG

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.

DRUG

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."

DRUG

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."

Trial Locations (1)

65807

Clinvest/A Division of Banyan Group, Inc., Springfield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Cady, Roger, M.D.

INDIV