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

This study has been terminated.
( Study terminated by sponsor )

Sponsors and Collaborators: Thomas Jefferson University
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

Genetics Home Reference related topics:   familial hemiplegic migraine   

MedlinePlus related topics:   Headache    Migraine   

ChemIDplus related topics:   Olanzapine   

U.S. FDA Resources

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.

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

Study ID Numbers:   SDS/ZYP/02, 080-19000-H55901
First Received:   September 13, 2005
Last Updated:   March 6, 2007
ClinicalTrials.gov Identifier:   NCT00203307
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Migraine Disorders
Headache
Olanzapine
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2008




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