Milnacipran for Migraine Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Smith, Mercy Health Research
ClinicalTrials.gov Identifier:
NCT01393522
First received: July 6, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Chronic Migraine
Drug: Milnacipran
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double Blind Placebo Control Trial of Milnacipran for Migraine Pain

Resource links provided by NLM:


Further study details as provided by Mercy Health Research:

Primary Outcome Measures:
  • Evaluating Headache Pain Reduction [ Time Frame: Will report change from baseline after the 90 day reporting period ] [ Designated as safety issue: No ]
    To evaluate the efficacy of milnacipran in headache pain reduction in subjects with chronic migraine (CM) without fibromyalgia

  • Evaluating the improvement of Quality of Life [ Time Frame: Changes from Visit 1 quality of life until study completion month 4 ] [ Designated as safety issue: No ]
    To evaluate the efficacy of milnacipran in improving quality of life in subjects with chronic migraine (CM) without fibromyalgia


Secondary Outcome Measures:
  • Migraine Prevention [ Time Frame: Will assess at day 30, day 60 and day 90 ] [ Designated as safety issue: No ]
    To evaluate the efficacy of milnacipran in migraine prevention in subjects with chronic migraine

  • Sleep and Energy [ Time Frame: Will assess at visit 2 and again at visit 5, study completion visit ] [ Designated as safety issue: No ]
    To evaluate the impact of milnacipran on sleep and energy in subjects with chronic migraine

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


Enrollment: 37
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393522

Locations
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
  More Information

No publications provided

Responsible Party: Timothy Smith, Vice President of Clinical Research, Mercy Health Research
ClinicalTrials.gov Identifier: NCT01393522     History of Changes
Other Study ID Numbers: SAV-MD-25
Study First Received: July 6, 2011
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mercy Health Research:
headache
migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Milnacipran
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014