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

July 6, 2011
December 16, 2013
June 2011
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01393522 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Milnacipran for Migraine Pain
A Randomized Double Blind Placebo Control Trial of Milnacipran for Migraine Pain

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Chronic Migraine
  • 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.
  • 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
  • Active Comparator: Milnacipran
    Intervention: Drug: Milnacipran
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01393522
SAV-MD-25
No
Timothy Smith, Mercy Health Research
Timothy Smith
Not Provided
Not Provided
Mercy Health Research
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP