N/A
N=37
Study Evaluated the Effectiveness of Milnacipran to Reduce Pain Levels in Individuals With Chronic Migraine
Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01393522 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Change in VAS Pain Severity — 3.23; 5.36 units on a scale — p=0.1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Milnacipran (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Timothy Smith
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in VAS Pain Severity |
3.23; 5.36 | 0.1 |
| PRIMARY Change in Migraine Specific Quality of Life - Restrictive |
21.01; 35.03 | 0.75 |
| PRIMARY Change in Migraine Specific Quality of Life - Preventive |
21.61; 31.26 | 0.16 |
| PRIMARY Change in Migraine Specific Quality of Life - Emotional |
29.89; 37.99 | 0.41 |
| SECONDARY Change in Days With Migraine Per Month From Baseline to 90 Days |
3.34; 4.62 | 0.33 |
| SECONDARY Change in Days With Non-Migraine Headache Per Month From Baseline to 90 Days |
2.35; 0.76 | 0.09 |
| SECONDARY Change in Days Using Headache Medication Per Month From Baseline to 90 Days |
1.28; 2.17 | 0.78 |
Summary
The purpose of this study is to determine if milnacipran taken twice daily is effective in reduction of headache pain.
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 /= 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
Data sourced from ClinicalTrials.gov (NCT01393522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.