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

NCT00203307 | Terminated Results

• 2 other identifiers: SDS/ZYP/02080-19000-H55901
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  84 day period on placebo compared to 84 day period on olanzapine

Secondary Outcomes (2)

• 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

  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.

  84 day period on olanzapine compared to 84 day period on placebo

Study Arms (2)

Olanzapine then Placebo

OTHER

Olazepam

Drug: Olanzapine during first intervention period and placebo during second intervention period

Placebo then olanzapine

OTHER

Drug: Placebo during first intervention period, then olanzapine during second intervention period

Interventions

Olanzapine during first intervention period and placebo during second intervention period DRUG

Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)

Olanzapine then Placebo

Placebo during first intervention period, then olanzapine during second intervention period DRUG

Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).

Placebo then olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Stephen D. Silberstein, M.D.- Principal Investigator
• Organization: Thomas Jefferson University/ Jefferson Headache Center

stephen.silberstein@jefferson.edu

215-955-2243

Study Officials

• Stephen D Silberstein

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: June 1, 2006
• Last Updated: August 25, 2011
• Results First Posted: August 10, 2011

Record last verified: 2011-08

Locations

US (1)