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A Research Study Examining the Use of Olanzapine for the Prevention of Migraine
This study has been terminated.
(Study terminated by sponsor)
Sponsor:
Thomas Jefferson University
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
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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 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 ]
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 ]
- 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 ]
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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
| 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 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |
ClinicalTrials.gov processed this record on July 18, 2017