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

Primary Purpose

Idiopathic Peripheral Neuropathy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Peripheral Neuropathy focused on measuring Milnacipran, Idiopathic Peripheral Neuropathy, Diabetic neuropathy, Neuropathic pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Milnacipran

Placebo

Arm Description

Patients will receive Milnacipran

Patients will receive Placebo

Outcomes

Primary Outcome Measures

Likert Pain Scale Score
The Likert Pain Scale Score is a psychometric scale commonly involved in research that employs questionnaires to measure the intensity of pain. It is used to determine the level of pain for research participants. The minimum score of 0 indicates "no pain" which is the better score and the maximum and total score of 10 indicates the "the worst possible pain" which is the worse outcome . Scores 1-3= Mild, scores 4-6= Moderate, scores 7-10= Severe. It is the most widely used approach to scaling responses in survey research. 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. The Unit of Measure is the scores on the scale.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2011
Last Updated
August 19, 2020
Sponsor
Columbia University
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01288937
Brief Title
A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
Official Title
A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
April 5, 2011 (Actual)
Primary Completion Date
October 22, 2014 (Actual)
Study Completion Date
December 23, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Forest Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Peripheral Neuropathy
Keywords
Milnacipran, Idiopathic Peripheral Neuropathy, Diabetic neuropathy, Neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
Patients will receive Milnacipran
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive Placebo
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Pill
Intervention Description
Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period), matching the schedule of the study drug.
Primary Outcome Measure Information:
Title
Likert Pain Scale Score
Description
The Likert Pain Scale Score is a psychometric scale commonly involved in research that employs questionnaires to measure the intensity of pain. It is used to determine the level of pain for research participants. The minimum score of 0 indicates "no pain" which is the better score and the maximum and total score of 10 indicates the "the worst possible pain" which is the worse outcome . Scores 1-3= Mild, scores 4-6= Moderate, scores 7-10= Severe. It is the most widely used approach to scaling responses in survey research. 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. The Unit of Measure is the scores on the scale.
Time Frame
Baseline, 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Brannagan III, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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