NINDS CRC Chronic Migraine Treatment Trial

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Anne Lindblad
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Propranolol; Topiramate

Criteria

Inclusion Criteria:

• History of chronic migraine for at least 6 months

• Age ≥ 18 years and age of migraine onset 60 or younger

• EKG performed in the last 12 months

Exclusion Criteria:

• Prior neuro-imaging suggesting secondary structural causes of headache

• Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder

• Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)

• History of kidney failure or nephrolithiasis

• A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control

• Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month

• Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol

• Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months