Idiopathic Peripheral Neuropathy Clinical Trial
Official title:
A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
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.
Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous system. Serotonin and noradrenaline are molecules made by the brain that affect how your body responds to 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. Many clinical trials for neuropathy pain are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber neuropathies. The information in this study will provide information on whether milnacipran also provide benefit as a medication for neuropathic pain. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03401073 -
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
|
Phase 2 |