CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 705 enrolled
Drug / intervention
Botulinum Toxin Type A +1 morebiological
Likely dose
Botulinum Toxin Type A: 155–195 U administered via 31–39 fixed-site, fixed-dose injections across seven head/neck muscle areas per treatment sessionAI-extracted
Key inclusion· 3
  • ✓Frequent migraine with ≥15 headache days per month
  • ✓≥4 distinct headache episodes lasting ≥4 hours
  • ✓≥50% of baseline headache days are migraine or probable migraine days
Key exclusion· 9
  • ✕Previous use of botulinum toxin of any serotype or immunization to botulinum toxin
  • ✕Any medical condition that increases risk with BOTOX exposure
  • ✕Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, or new daily persistent headache
  • ✕Use of prophylactic headache medication within 28 days prior to week -4

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00168428
NCT00168428Phase 3Completed
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A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

Allergan·interventional·Posted Sep 15, 2005·Updated Nov 18, 2013

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin Type A and placebo (saline) for Migraine Disorders. Completed, enrolled 705 participants across 6 sites in 6 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesCanada, Croatia, Germany, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2007
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.8 years ago

Interventions

Botulinum Toxin Type Abiological

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.

placebo (saline)other

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.