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

NCT01288937 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: AAAF3404
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Peripheral Neuropathy

Keywords

Milnacipran; Idiopathic Peripheral Neuropathy; Diabetic neuropathy; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 9 weeks

Study Arms (2)

Milnacipran

EXPERIMENTAL

Patients will receive Milnacipran

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

Patients will receive Placebo

Drug: Placebo

Interventions

Milnacipran DRUG

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)

Also known as: Savella

Milnacipran

Placebo DRUG

Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period), matching the schedule of the study drug.

Also known as: Placebo Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Study was terminated and target accrual was unmet due to pre-screening exclusion criteria: 1) excluded concomitant medicines; and 2) patients who had prediabetes.

Results Point of Contact

• Title: Thomas H. Brannagan, MD
• Organization: Columbia University

tb2325@cumc.columbia.edu

(212) 305-0405

Study Officials

• Thomas H Brannagan III, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Neurology

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: April 5, 2011
• Primary Completion: October 22, 2014
• Study Completion: December 23, 2014
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-08

Locations

US (1)