Overview

This trial is active, not recruiting.

Condition idiopathic peripheral neuropathy
Treatments milnacipran, placebo
Sponsor Columbia University
Collaborator Forest Laboratories
Start date November 2010
End date October 2014
Trial size 52 participants
Trial identifier NCT01288937, AAAF3404

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
milnacipran Savella
Patients will be randomly assigned to receive either milnacipran 100 mg/day (including a 1week 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)
(Placebo Comparator)
placebo
Patients will be randomly assigned to placebo for 9wks (including a 1week 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

Primary Outcomes

Measure
Change in average 11 point Likert pain scale (0-10).
time frame: 9 weeks

Secondary Outcomes

Measure
Change in Rand-36 Item Quality of Life Scale
time frame: 9 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
Principal investigator Thomas H Brannagan III, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Columbia University.