Status:
TERMINATED
A Research Study Examining the Use of Olanzapine for the Prevention of Migraine
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00203307
Start Date
May 1 2004
End Date
June 1 2006
Last Update
August 25 2011
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107