Milnacipran for Migraine Pain
This study is currently recruiting participants.
Verified September 2011 by Mercy Health Research
Sponsor:
Mercy Health Research
Information provided by:
Mercy Health Research
ClinicalTrials.gov Identifier:
NCT01393522
First received: July 6, 2011
Last updated: September 22, 2011
Last verified: September 2011
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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
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | April 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393522
Contacts
| Contact: Timothy R Smith, MD | 314-251-8890 | mercyhealthresearch@mercy.net |
Locations
| United States, Missouri | |
| Mercy Health Research | Recruiting |
| St. Louis, Missouri, United States, 63141 | |
| Contact 314-251-8893 mercyhealthresearch@mercy.net | |
| Principal Investigator: Timothy R Smith, MD | |
| United States, North Carolina | |
| Headache Wellness Center | Recruiting |
| Greensboro, North Carolina, United States, 27405 | |
| Contact: Kathryn Poynter, RN 336-574-8001 | |
| Principal Investigator: Marshall C Freeman, MD | |
Sponsors and Collaborators
Mercy Health Research
More Information
No publications provided
| Responsible Party: | Timothy R. Smith, MD, 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: | September 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mercy Health Research:
|
headache migraine |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Milnacipran Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013