Clinical trial NCT01319825: Preventive Treatment of Episodic and Chronic Migraine
Official title: Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine With Aura
Migraine Without Aura
Chronic Migraine
Lead sponsor: California Medical Clinic for Headache
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
timeFrame: 4 months
Secondary outcomes:
measure: Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
timeFrame: 4 months
measure: Improvement in headache index score
timeFrame: 4 months
measure: Reduction in the number of days of headache related disability/impairment
timeFrame: 4 months
measure: Tolerability
timeFrame: 4 months
measure: Use of rescue medications
timeFrame: 4 months
measure: Quality of life measures
timeFrame: 4 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
Study officials:
affiliation: California Medical Clinic for Headache
name: David B Kudrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.