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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
California Medical Clinic for Headache
Santa Monica, California, United States
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
Time frame: 4 months
Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
Time frame: 4 months
Improvement in headache index score
Headache index is defined by headache severity x headache duration.
Time frame: 4 months
Reduction in the number of days of headache related disability/impairment
Time frame: 4 months
Tolerability
Assessment of adverse events
Time frame: 4 months
Use of rescue medications
To assess the continued need for acute headache treatments during the study period.
Time frame: 4 months
Quality of life measures
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.