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 (Responsible Party):	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 during first intervention period and placebo during second intervention period Drug: Placebo during first intervention period, then olanzapine during second intervention period

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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. [ Time Frame: 84 day period on placebo compared to 84 day period on olanzapine ] [ Designated as safety issue: No ]
Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present*.

Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112.

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 [ Time Frame: each 28 day interval of active treatment c ompared to placebo ] [ Designated as safety issue: No ]
Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject. [ Time Frame: 84 day period on olanzapine compared to 84 day period on placebo ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	May 2004
Study Completion Date:	June 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Olanzapine then Placebo Olazepam	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)
Placebo then olanzapine	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).

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

Responsible Party:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203307 History of Changes
Other Study ID Numbers:	SDS/ZYP/02, 080-19000-H55901
Study First Received:	September 13, 2005
Results First Received:	May 24, 2011
Last Updated:	August 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012