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

This study has been terminated.

( Study terminated by sponsor )

Study NCT00203307 Information provided by Thomas Jefferson University

First Received on September 13, 2005. Last Updated on August 23, 2011 History of Changes

Results First Received: May 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Migraine
Interventions:	Drug: Olanzapine during first intervention period and placebo during second intervention period Drug: Placebo during first intervention period, then olanzapine during second intervention period

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Olanzapine First, Then Placeb	Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
Placebo First, Then Olanzapine	Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).

Participant Flow for 2 periods

Period 1: First Intervention

	Olanzapine First, Then Placeb	Placebo First, Then Olanzapine
STARTED	3 ^[1]	0
COMPLETED	1	0
NOT COMPLETED	2	0
Adverse Event	2	0

[1]	Double-blind cross-over design. Study terminated early. Results not analyzed.

Period 2: Second Intervention

	Olanzapine First, Then Placeb	Placebo First, Then Olanzapine
STARTED	1 ^[1]	0
COMPLETED	1	0
NOT COMPLETED	0	0

[1]	2 subjects dropped out of the 1st intervention period, due to fatugue.

Baseline Characteristics

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Reporting Groups

	Description
Olanzapine First, Then Placeb	Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
Placebo First, Then Olanzapine	Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).

Baseline Measures

	Olanzapine First, Then Placeb	Placebo First, Then Olanzapine	Total
Number of Participants [units: participants]	3	0	3
Age [units: participants]
<=18 years	0		0
Between 18 and 65 years	3		3
>=65 years	0		0
Age [units: years] Mean ± Standard Deviation	50 ± 3		50 ± 3
Gender [units: participants]
Female	2		2
Male	1		1
Region of Enrollment [units: participants]
United States	3		3

Outcome Measures

1. Primary:

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 ]

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2. Secondary:

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 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

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 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Stephen D. Silberstein, M.D.- Principal Investigator
Organization: Thomas Jefferson University/ Jefferson Headache Center
phone: 215-955-2243
e-mail: stephen.silberstein@jefferson.edu

No publications provided

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
Health Authority:	United States: Food and Drug Administration