Milnacipran for Migraine Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393522
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Timothy Smith, Mercy Research

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

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Milnacipran Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double Blind Placebo Control Trial of Milnacipran for Migraine Pain
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: Milnacipran Drug: Milnacipran
titration schedule starting with 12.5mg per day increasing to 50mg twice a day, starting with day 1 to day 90 and then will taper down.

Placebo Comparator: Sugar Pill Drug: Placebo
Tablet will be titrated 1 tablet once a day increased per protocol to 2 tablets twice a day, with a starting dose of 12.5mg per day to 50 mg twice a day

Primary Outcome Measures :
  1. Evaluating Headache Pain Reduction [ Time Frame: Will report change from baseline after the 90 day reporting period ]
    To evaluate the efficacy of milnacipran in headache pain reduction in subjects with chronic migraine (CM) without fibromyalgia

  2. Evaluating the improvement of Quality of Life [ Time Frame: Changes from Visit 1 quality of life until study completion month 4 ]
    To evaluate the efficacy of milnacipran in improving quality of life in subjects with chronic migraine (CM) without fibromyalgia

Secondary Outcome Measures :
  1. Migraine Prevention [ Time Frame: Will assess at day 30, day 60 and day 90 ]
    To evaluate the efficacy of milnacipran in migraine prevention in subjects with chronic migraine

  2. Sleep and Energy [ Time Frame: Will assess at visit 2 and again at visit 5, study completion visit ]
    To evaluate the impact of milnacipran on sleep and energy in subjects with chronic migraine

  3. Anxiety and Depression [ Time Frame: At screening visit 1, visit 2, visit 3, visit 4 and visit 5 study completion ]
    To evaluate the relationship of baseline anxiety and depression on the efficacy of milnacipran for the above outcome measures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393522

United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, North Carolina
Headache Wellness Center
Greensboro, North Carolina, United States, 27405
Sponsors and Collaborators
Timothy Smith

Responsible Party: Timothy Smith, Vice President of Clinical Research, Mercy Research Identifier: NCT01393522     History of Changes
Other Study ID Numbers: SAV-MD-25
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by Timothy Smith, Mercy Research:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents