Expired Study
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Philadelphia, Pennsylvania 19107


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.


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


Study is Available At:


Original ID:

SDS/ZYP/02


NCT ID:

NCT00203307


Secondary ID:

080-19000-H55901


Study Acronym:


Brief Title:

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


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.


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thomas Jefferson University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Study terminated by sponsor


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephen D Silberstein
Principal Investigator
Thomas Jefferson University

Study Dates

Start Date:May 2004
Completion Date:June 2006
Completion Type:Actual
Primary Completion Date:March 2006
Primary Completion Type:Actual
Verification Date:August 2011
Last Changed Date:August 23, 2011
First Received Date:September 13, 2005
First Results Date:May 24, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Olanzapine during first intervention period and pl
Description:Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)
Arm Name:Olanzapine then Placebo
Intervention Type:Drug
Name:Placebo during first intervention period, then ola
Description:Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).
Arm Name:Placebo then olanzapine

Study Arms

Study Arm Type:Other
Arm Name:Placebo then olanzapine
Study Arm Type:Other
Arm Name:Olanzapine then Placebo
Description:Olazepam

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Thomas Jefferson University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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