A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
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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 |
| 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 |
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | October 2013 (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 or 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 (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily) Other Name: Savella
|
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 |
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| Contact: Thomas H Brannagan, MD | 212-305-0405 |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Thomas H Brannagan, MD 212-305-0405 | |
| Contact: Stacy-Ann Mano, BS 212-305-6035 | |
| Principal Investigator: Thomas H Brannagan, MD | |
| Sub-Investigator: Louis H Weimer, MD | |
| 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: | November 15, 2012 |
| 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 Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders 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 May 21, 2013