A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
Condition: Idiopathic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: Milnacipran; Placebo
Intervention description: Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):
Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily); Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period), matching the schedule of the study drug.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Milnacipran; Idiopathic Peripheral Neuropathy; Diabetic neuropathy; Neuropathic pain

Summary:

      This is an 11-week randomized, double-blind, placebo-controlled trial of Milnacipran 100 mg/d
      in patients with idiopathic neuropathic pain. Milnacipran, a dual norepinephrine and
      serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with
      fibromyalgia and may be useful to treat patients with painful peripheral neuropathy.

      The primary outcome will be assessed by the change in daily averaged weekly 0-10 pain
      intensity score, from baseline to week 9, by intention to treat analysis. The same analysis
      will be used on several secondary measures including daily averaged weekly 0-10 pain
      intensity score the sleep interference scale and the Rand-36 quality of life scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age 18 to 80 years

          -  Patients with signs and symptoms of a peripheral neuropathy, with either abnormal
             nerve conductions or abnormal epidermal nerve fiber density with neuropathic pain.

          -  Pain will have been present for at least 6 months

          -  Patients may be on other medications for neuropathic pain (eg, antiepileptic
             medications, opiates or non steroidal antiinflammatories); however they must be on a
             stable dose for 4 weeks prior to, with no plan to change during the study

          -  All patients must have had a normal fasting glucose or B12, thyroid stimulating
             hormone, and serum protein electrophoresis, since the onset of their symptoms.

        Exclusion Criteria:

          -  Other cause of neuropathy (eg, diabetic neuropathy, toxic neuropathy, HIV neuropathy,
             celiac neuropathy, inherited neuropathy)

          -  Unstable angina

          -  Use of another serotonin and norepinephrine reuptake inhibitors (eg, duloxetine,
             venlafaxine), tricyclic antidepressants, monoamine oxidase inhibitors (MAOI) or
             selective serotonin reuptake inhibitors

          -  Myocardial infarction stroke or life threatening arrhythmia within the last 6 months

          -  HIV infection

          -  Hepatic or renal failure

          -  Pregnancy

          -  narrow angle glaucoma

          -  History of epilepsy or a seizure