Clinical trial NCT01393522: Study Evaluated the Effectiveness of Milnacipran to Reduce Pain Levels in Individuals With Chronic Migraine
Official title: A Randomized Double Blind Placebo Control Trial of Milnacipran for Migraine Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Keywords: headache
migraine
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if milnacipran taken twice daily is effective in reduction of headache pain.

Detailed description: Milnacipran is a serotonin norepinephrine reubtake inhibitor (SNRI) approved for the management of fibromyalgia in the United States.

Migraine and fibromyalgia have significant co-morbidity. Of 100 patients with fibromyalgia, 76% had chronic headaches, of whom 63% had migraine. Interestingly, general measures of pain, disability, sleep quality, and psychological distress were similar in individuals with fibromyalgia with and without headache. Conversely, the prevalence of fibromyalgia in women with migraine was reported as 22%, and at a headache referral center, 36% of headache patients had fibromyalgia.

Because of significant co-morbidity, as well as the likelihood of shared pathophysiologic mechanisms, there is reason to believe that a medication effective for fibromyalgia might reduce migraine pain, especially where the pain has taken on the nature of a chronic pain disorder, as in chronic migraine. The current study evaluated the benefits of milnacipran in individuals with chronic migraine.

Patients with chronic migraine were randomized to either Milnacipran or Placebo. Patients completed 30 days of baseline followed by 90 days of headache diaries while taking assigned medication. Primary outcomes were reduction in pain severity and improvement in migraine specific quality of life (MSQ) while secondary outcomes included reduction in migraine and non-migraine headache days and symptomatic use of medication for migraine. Independent sample t-tests were used to evaluate the changes in primary and secondary measures between the two groups.

Eligibility criteria: Inclusion Criteria:

* Individuals between the age of 18 and 65
* Headache fulfills ICHD-2 criteria for: chronic migraine, or probable medication overuse headache where individual headaches meet criteria for migraine
* At least 15 headache days/month and at least 8 migraine or probable migraine days/month for the past 3 months, by patient report (including days of headache relieved with a triptan or related compound).
* Age at onset of chronic migraine \< 60 years old

Exclusion Criteria:

* Pregnancy or attempting conception
* Unable to read or write English
* Use of Opiates \>/= 10 days per month
* Subject has failed \>/= 4 adequate preventive trials of antidepressant medications due to lack of efficacy; at least one trial included another SNRI.(An adequate preventive trial defined as at least 6 weeks on therapeutic dose \[150mg of amitriptyline or nortriptyline or other tricyclic, 150mg of venlafaxine, 60mg of duloxetine\])
* Subjects on antidepressant medications, including SNRIs who cannot safely withdraw from those medications, in the assessment of the PI. Subjects on other headache preventives (beta blockers, antiepileptic drugs), at stable dose for at least three months, will be allowed to participate.

A. Subjects on other headache preventives may be included in the study if the medication has been at a stable dose for 3 months.

* Presence of fibromyalgia or another pain or medical disorder that would make it difficult for patient to distinguish headache-related quality of life from overall health related quality of life.
* Uncontrolled or unstable psychiatric disorder (PHQ-9 score or GAD-7 score \>15 with sentinel questions \>/=4, or in opinion of examiner), or anticipated need for change in psychotropic medications during duration of study period; or suicidality.
* Chronic kidney disease, liver disease, or any poorly controlled medical condition

Primary outcomes:
measure: Change in VAS Pain Severity
timeFrame: Baseline and 90 days
measure: Change in Migraine Specific Quality of Life - Restrictive
timeFrame: Baseline and 90 days
measure: Change in Migraine Specific Quality of Life - Preventive
timeFrame: Baseline and 90 days
measure: Change in Migraine Specific Quality of Life - Emotional
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Change in Days With Migraine Per Month From Baseline to 90 Days
timeFrame: Baseline and 90 days
measure: Change in Days With Non-Migraine Headache Per Month From Baseline to 90 Days
timeFrame: Baseline and 90 days
measure: Change in Days Using Headache Medication Per Month From Baseline to 90 Days
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
Study officials:
affiliation: Mercy Research
name: Timothy Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: