Preventive Treatment of Episodic and Chronic Migraine

Study Overview
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Brief Summary
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This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.

Detailed Description
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Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.

Official Title
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Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.

Conditions
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Migraine With Aura, Migraine Without Aura, Chronic Migraine

Intervention / Treatment
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* Drug: milnacipran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine with or without aura or chronic migraine. 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 pregnant, lactating or planning a pregnancy in the next year. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: milnacipran|100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of migraine days per month in the last month of stable dosing compared to baseline. |  | 4 months | 
| Improvement in headache index score | Headache index is defined by headache severity x headache duration. | 4 months | 
| Reduction in the number of days of headache related disability/impairment |  | 4 months | 
| Tolerability | Assessment of adverse events | 4 months | 
| Use of rescue medications | To assess the continued need for acute headache treatments during the study period. | 4 months | 
| Quality of life measures |  | 4 months |