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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milnacipran | Drug | 100 mg and 200 mg orally daily for a total of 4 months including a one month titration period. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David B Kudrow, MD | Contact | 310-315-1456 | dbkudrow@earthlink.net |
| Name | Affiliation | Role |
|---|---|---|
| David B Kudrow, MD | California Medical Clinic for Headache | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24030685 | Derived | 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. |
| Label | URL |
|---|---|
| California Medical Clinic for Headache | View source |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |