A Research Study Examining the Use of Olanzapine for the Prevention of Migraine - Full Text View

Sponsor:	Thomas Jefferson University
Collaborator:	Eli Lilly and Company
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203307

Purpose

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.

Condition	Intervention
Migraine	Drug: Olanzapine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Difference in migraine headache periods during the active treatment period as compared to the placebo treatment period, per subject.

Secondary Outcome Measures:

Reduction of migraine attack frequency during each 28-day interval of the active treatment period as compared to each 28-day interval of the placebo treatment period, per subject. Individual migraine attacks are separated by 48-hours pain free time. A
Reduction in days using an acute headache treatment during the active treatment period as compared to the placebo treatment period, per subject.

Estimated Enrollment:	46
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who are male or female between the ages of 18 and 65, inclusive
Subjects who have a history of migraine with or without aura as defined by IHS criteria, for at least one year prior to screening
Subjects who experience between 3 and 10 migraine attacks per month, for the three months preceding screening
Subjects who have no more than 15 headache days per month
Subjects who have been on a stable dose (no clinically significant changes) of all daily medications, for any indication, from 28 days prior to screening through the duration of the trial.
Women who are using, or agree to use for the duration of the study, a medically acceptable form of contraception (as determined by the investigator), if female of childbearing potential.
Subjects who are able to understand and comply with all study requirements
Subjects who provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

Women who are pregnant or lactating
Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability (subjects with QTC interval greater than 450ms will be excluded)
Subjects currently taking, or have taken within the thirty days prior to screening, any neuroleptics > 1 day per week (such as Geodon, Zyprexa, Compazine, Phenergan, Seroquel and other drugs in the same class)
Subjects currently taking or have taken within 4-weeks prior to screening any medication for the prevention of migraine
Subjects who have failed more than two adequate trials of migraine prophylaxis, as determined by investigator
Subjects who experience significant orthostatic hypotension, as determined by the investigator
Subjects who, in the investigators opinion, have a history or have evidence of a medical condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
Subjects who, in the investigators opinion, have a history or have evidence of a psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial.
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203307

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Eli Lilly and Company

Investigators

Principal Investigator:

Stephen D Silberstein

Thomas Jefferson University

More Information

No publications provided

Study ID Numbers:	SDS/ZYP/02, 080-19000-H55901
Study First Received:	September 13, 2005
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00203307 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Diseases
Central Nervous System Depressants

Headache Disorders, Primary
Brain Diseases
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Autonomic Agents
Migraine Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010