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

Primary Purpose

Migraine

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olanzapine during first intervention period and placebo during second intervention period
Placebo during first intervention period, then olanzapine during second intervention period
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jefferson Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Olanzapine then Placebo

Placebo then olanzapine

Arm Description

Olazepam

Outcomes

Primary Outcome Measures

Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
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
Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.

Full Information

First Posted
September 13, 2005
Last Updated
August 23, 2011
Sponsor
Thomas Jefferson University
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00203307
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Study terminated by sponsor
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine then Placebo
Arm Type
Other
Arm Description
Olazepam
Arm Title
Placebo then olanzapine
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Olanzapine during first intervention period and placebo during second intervention period
Intervention Description
Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)
Intervention Type
Drug
Intervention Name(s)
Placebo during first intervention period, then olanzapine during second intervention period
Intervention Description
Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).
Primary Outcome Measure Information:
Title
Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
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 84. Second treatment period: day 113-196. Washout phase is day 85-112.
Time Frame
84 day period on placebo compared to 84 day period on olanzapine
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D Silberstein
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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

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