A Research Study Examining the Use of Olanzapine for the Prevention of Migraine
NCT00203307 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2011-08-25
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
Interventions
- 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).
Sponsors & Collaborators
- collaborator INDUSTRY
-
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Stephen D Silberstein · Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Primary Completion
- 2006-03-31
- Completion
- 2006-06-30
Countries
- United States
Study Locations
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