A Research Study Examining the Use of Olanzapine for the Prevention of Migraine
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|ClinicalTrials.gov Identifier: NCT00203307|
Recruitment Status : Terminated (Study terminated by sponsor)
First Posted : September 20, 2005
Results First Posted : August 10, 2011
Last Update Posted : August 25, 2011
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||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.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||June 2006|
Olanzapine then Placebo
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).
- 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 ]
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203307
|United States, Pennsylvania|
|Jefferson Headache Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D Silberstein||Thomas Jefferson University|