NCT00203307

A Research Study Examining the Use of Olanzapine for the Prevention of Migraine

A Single-Site, Double-Blind, Placebo-Controlled Cross-Over Trial Examining the Safety and Efficacy of Olanzapine Taken Daily for the Prevention of Episodic Migraine.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental for the purposes of this research study. The Jefferson Headache Center at Thomas Jefferson University has developed this clinical study to evaluate the safety and effectiveness of Olanzapine in preventing migraine headaches.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Olanzapine during first intervention period and placebo during second intervention period	Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)
DRUG	Placebo during first intervention period, then olanzapine during second intervention period	Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-03-01
• Completion: 2006-06-01
• First posted: 2005-09-20
• Last updated: 2011-08-25
• Results posted: 2011-08-10

Locations

1 site across 1 country: United States