Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2011-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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milnacipran
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
Eligibility Criteria
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Inclusion Criteria
* Subject age 18 to 70.
* At least 2 migraine attacks per month.
* Willing ang able to give written informed consent.
* Willing and able to complete the entire course of the study and to comply with study instructions.
* Willing to taper and discontinue their current preventive medications.
Exclusion Criteria
* Subject is female of child-bearing potential and not taking adequate forms of birth control.
* Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
* Previous failure of four or more adequate trials of preventive medication.
* Currently on any form of antidepressant for depression and not able to discontinue.
* Currently demonstrating medication overuse headache.
* Currently has uncontrolled narrow angle glaucoma.
* Currently taking monoamine oxidase inhibitors.
* Subject has a history of seizures.
* Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.
18 Years
70 Years
ALL
No
Sponsors
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California Medical Clinic for Headache
OTHER
Responsible Party
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California Medical Clinic for Headache
Principal Investigators
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David B Kudrow, MD
Role: PRINCIPAL_INVESTIGATOR
California Medical Clinic for Headache
Locations
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California Medical Clinic for Headache
Santa Monica, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Engel ER, Kudrow D, Rapoport AM. A prospective, open-label study of milnacipran in the prevention of headache in patients with episodic or chronic migraine. Neurol Sci. 2014 Mar;35(3):429-35. doi: 10.1007/s10072-013-1536-0. Epub 2013 Sep 13.
Related Links
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California Medical Clinic for Headache
Other Identifiers
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SAV-MD-26
Identifier Type: -
Identifier Source: org_study_id
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