NINDS CRC Chronic Migraine Treatment Trial

NCT00772031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2012-01-24

Study results available
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Summary

The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

Conditions

  • Chronic Migraine

Interventions

DRUG

propranolol LA

Propranolol LA up to 240 mg/day

DRUG

topiramate

Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.

DRUG

placebo

an inactive substance

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • Ortho-McNeil Janssen Scientific Affairs, LLC

    collaborator INDUSTRY
  • Anne Lindblad

    lead INDUSTRY

Principal Investigators

  • David Dodick, MD · Professor of Neurology, Mayo Clinic

  • Stephen D. Silberstein, MD · Professor of Neurology, Thomas Jefferson University

  • Deborah Hirtz, MD · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00772031 on ClinicalTrials.gov