Preventive Treatment of Episodic and Chronic Migraine

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Medical Clinic for Headache
• Treatments: Levomilnacipran; Milnacipran

Criteria

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.