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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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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). |
| Total | Total of all reporting groups |
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 ] |
| 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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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 |
|---|
| No text entered. |
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
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 |