Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Allergan

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Eligibility Criteria

Inclusion Criteria

More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).

History of chronic migraine

Treatment Details

Interventions

onabotulinumtoxinA (Neurotoxin)
Topiramate (Anticonvulsant)

Participant Groups

2Treatment groups

Active Control

Group I: TopiramateActive Control1 Intervention

Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.

Group II: BOTOX®Active Control1 Intervention

155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.