Milnacipran for Migraine Pain



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:June 2011
End Date:December 2013

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A Randomized Double Blind Placebo Control Trial of Milnacipran for Migraine Pain

The purpose of this study is to determine if milnacipran taken twice daily is effective in
reduction of headache pain.


Inclusion Criteria:

- Individuals between the age of 18 and 65

- Headache fulfills ICHD-2 criteria for: chronic migraine, or probable medication
overuse headache where individual headaches meet criteria for migraine

- At least 15 headache days/month and at least 8 migraine or probable migraine
days/month for the past 3 months, by patient report (including days of headache
relieved with a triptan or related compound).

- Age at onset of chronic migraine < 60 years old

Exclusion Criteria:

- Pregnancy or attempting conception

- Unable to read or write English

- Use of Opiates >/= 10 days per month

- Subject has failed >/= 4 adequate preventive trials of antidepressant medications due
to lack of efficacy; at least one trial included another SNRI.(An adequate preventive
trial defined as at least 6 weeks on therapeutic dose [150mg of amitriptyline or
nortriptyline or other tricyclic, 150mg of venlafaxine, 60mg of duloxetine])

- Subjects on antidepressant medications, including SNRIs who cannot safely withdraw
from those medications, in the assessment of the PI. Subjects on other headache
preventives (beta blockers, antiepileptic drugs), at stable dose for at least three
months, will be allowed to participate.

A. Subjects on other headache preventives may be included in the study if the medication
has been at a stable dose for 3 months.

- Presence of fibromyalgia or another pain or medical disorder that would make it
difficult for patient to distinguish headache-related quality of life from overall
health related quality of life.

- Uncontrolled or unstable psychiatric disorder (PHQ-9 score or GAD-7 score >15 with
sentinel questions >/=4, or in opinion of examiner), or anticipated need for change in
psychotropic medications during duration of study period; or suicidality.

- Chronic kidney disease, liver disease, or any poorly controlled medical condition
We found this trial at
2
sites
Greensboro, North Carolina 27405
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Greensboro, NC
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St. Louis, Missouri 63141
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St. Louis, MO
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