A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Thomas Brannagan, Columbia University
ClinicalTrials.gov Identifier:
NCT01288937
First received: February 1, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Idiopathic Peripheral Neuropathy
Drug: Milnacipran
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in average 11 point Likert pain scale (0-10). [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Patients will fill out a pain diary from baseline to end of treatment. This will be used to assess if there was a reduction in pain of the daily averaged weekly 0-10 pain scale at week 9 compared to the baseline.


Secondary Outcome Measures:
  • Change in Rand-36 Item Quality of Life Scale [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: November 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran Drug: Milnacipran

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)

Other Name: Savella
Placebo Comparator: Placebo Drug: 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


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288937

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Forest Laboratories
Investigators
Principal Investigator: Thomas H Brannagan III, MD Columbia University
  More Information

No publications provided

Responsible Party: Thomas Brannagan, Professor of Clinical Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT01288937     History of Changes
Other Study ID Numbers: AAAF3404
Study First Received: February 1, 2011
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Milnacipran
Idiopathic Peripheral Neuropathy
Diabetic neuropathy
Neuropathic pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular 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 September 18, 2014