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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
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   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
Enrollment 3

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Hide Arm/Group Description Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period) Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
Period Title: First Intervention
Started 3 [1] 0
Completed 1 0
Not Completed 2 0
Reason Not Completed
Adverse Event             2             0
[1]
Double-blind cross-over design. Study terminated early. Results not analyzed.
Period Title: Second Intervention
Started 1 [1] 0
Completed 1 0
Not Completed 0 0
[1]
2 subjects dropped out of the 1st intervention period, due to fatugue.
Arm/Group Title Olanzapine First, Then Placeb Placebo First, Then Olanzapine Total
Hide Arm/Group Description Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period) Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period). Total of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
<=18 years 0 0
Between 18 and 65 years 3 3
>=65 years 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 0 participants 3 participants
50  (3) 50  (3)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female 2 2
Male 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 0 participants 3 participants
3 3
1.Primary Outcome
Title Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
Hide Description

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.

Time Frame 84 day period on placebo compared to 84 day period on olanzapine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Hide Arm/Group Description:
Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
Overall Number of Participants Analyzed 3 0
Mean (Standard Deviation)
Unit of Measure: headache periods
0  (0)
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame each 28 day interval of active treatment c ompared to placebo
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
Hide Description [Not Specified]
Time Frame 84 day period on olanzapine compared to 84 day period on placebo
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Hide Arm/Group Description Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period) Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
All-Cause Mortality
Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olanzapine First, Then Placeb Placebo First, Then Olanzapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/0    
Nervous system disorders     
lethargy [1]  2/3 (66.67%)  0/0  0
[1]
2 subjects withdrew from study before completion due to lethargy
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen D. Silberstein, M.D.- Principal Investigator
Organization: Thomas Jefferson University/ Jefferson Headache Center
Phone: 215-955-2243
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203307     History of Changes
Other Study ID Numbers: SDS/ZYP/02
080-19000-H55901
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: May 24, 2011
Results First Posted: August 10, 2011
Last Update Posted: August 25, 2011