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Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

NCT00846495 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-01-13

Study results available
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Summary

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Conditions

Interventions

DRUG

topiramate

topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks

DRUG

frovatriptan

frovatriptan 5mg tab during premonitory phase of migraine

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Clinvest

    lead INDIV

Principal Investigators

  • Roger K Cady, MD · Clinvest

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846495 on ClinicalTrials.gov