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

This study has been terminated.
(Study terminated by sponsor)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203307
First received: September 13, 2005
Last updated: August 23, 2011
Last verified: August 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014