Milnacipran for Lumbosacral Radicular Pain

NCT01777581 | Completed Phase 4 Results DMC

• 2 other identifiers: Pro00020888SAV-MD-12
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease.

Conditions

Radicular Pain Related to Lumbosacral Disc Disease

Keywords

sciatica radiculopathy lumbar disc lumbosacral disc

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)

  The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.

  baseline and 10 weeks

Secondary Outcomes (6)

• VAS Related to Nociceptive Pain Component (VAS-Noc)

  baseline and 10 weeks

• SF-36 (Short Form)

  baseline and 10 weeks

• Oswestry Low Back Pain Disability Questionnaire

  baseline and 10 weeks

• Neuropathic Pain Questionnaire

  baseline and 10 weeks

• Beck Depression Inventory (BDI-II)

  baseline and 10 weeks

Study Arms (2)

milnacipran

EXPERIMENTAL

Milnacipran, flexibly dosed

Drug: Milnacipran

Sugar pill (placebo)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Milnacipran DRUG

Also known as: Savella

milnacipran

Placebo DRUG

Sugar pill (placebo)

Eligibility Criteria

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

You may qualify if:

• Subject is a male or female adult outpatient age 18 or older at the time of consent.
• Subject experiences chronic (\> 6 months) radicular pain at least 5 days a week described as sharp or shooting below the level of the knee associated with lumbar or sacral disk disease without suspicion of recent injury; remote (\>1 year ago) history of surgical intervention (e.g. "failed back syndrome") is allowed provided current symptoms meet severity criterion.
• Subject-rated VAS specifically related to radicular pain \> or = 40 mm at screen and baseline visits
• Subject has an understanding, ability and willingness to fully comply with study procedures and restrictions.
• Subject has the ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.

You may not qualify if:

• Subjects unable to complete assessments due to language or cognitive impairment
• Subjects treated with antidepressant or anticonvulsant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
• Subjects taking monoamine oxidase inhibitors
• Subjects who have received procedural intervention within 3 months of screen.
• Subjects with known sensitivity to milnacipran.
• Subjects unable to complete the questionnaires due to language or cognitive impairment.
• Subjects with a history of bipolar disorder or psychosis as confirmed by the Mini International Neuropsychiatric Interview (MINI).
• Subject currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual for Mental Disorders, Text Revision criteria (excluding nicotine).
• Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or who has a prior history of or are currently demonstrating active suicidal ideation.
• Subject has any clinically significant electrocardiogram (ECG) or clinically significant laboratory abnormality (including a positive urine drug screen) at Screening.
• Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
• Subjects who are pregnant or who are nursing
• Subjects who do not agree to use adequate and reliable contraception throughout the study.
• Subject previously completed, discontinued or was withdrawn from this study.
• Subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening.

Sponsors & Collaborators

• Duke University: lead
• Forest Laboratories: collaborator

Related Publications (1)

• Marks DM, Pae CU, Patkar AA. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease. Prim Care Companion CNS Disord. 2014 Aug 14;16(4):10.4088/PCC.14m01658. doi: 10.4088/PCC.14m01658. eCollection 2014.

  PMID: 25664215 DERIVED

MeSH Terms

Interventions

Milnacipran

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Marks, MD
• Organization: Duke University Medical Center

d.marks@duke.edu

919 668-2859

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: January 29, 2013
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 23, 2014
• Results First Posted: May 23, 2014

Record last verified: 2014-04