Open-label Milnacipran for Persistent Knee Pain One Year After Total Knee Arthroplasty (TKA)

NCT01780389 | Completed Phase 4 Results

• 2 other identifiers: Pro00017445SAV-MD-08
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The current study examines the effects of milnacipran in patients who have chronic persistent knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for a pain-relieving effect.

Conditions

Knee Pain After Total Knee Arthroplasty; Osteoarthritis Pain

Keywords

Knee; Pain; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Pain Visual Analogue Scale(VAS).

  The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm: 0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity.

  baseline and endpoint 12 weeks

Secondary Outcomes (7)

• Change in Knee Society Score (KSS).

  between baseline and endpoint (12 weeks or early termination)

• Global Rating of Change

  Endpoint (12 weeks or early termination)

• Change in Total Score of Multidimensional Fatigue Inventory (MFI-20)

  Baseline to endpoint (12 weeks or early termination)

• Change in the Beck Depression Inventory (BDI-II)

  Baseline to endpoint (12 weeks or early termination)

• Change in the Montgomery Asberg Depression Rating Scale

  Between baseline and endpoint (12 weeks or early termination)

Study Arms (1)

Milnacipran

EXPERIMENTAL

Open-label flexibly dosed milnacipran

Drug: Open-label flexibly dosed milnacipran

Interventions

Open-label flexibly dosed milnacipran DRUG

Also known as: Savella

Milnacipran

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 has chronic persistent pain 1 year after TKA without history of new injury, infection, or implant failure.
• Subject has VAS \> 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 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 of Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) 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 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 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.
• Subjects treated with antidepressant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
• Subjects with known sensitivity to milnacipran.
• Subjects with liver disease or reduced liver function
• Subjects with obstructive uropathies
• Subjects who consume alcohol in amounts viewed by the Investigator to be contraindicated
• Subjects taking monoamine oxidase inhibitors

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Marks DM, Bolognesi MP. Open-label milnacipran for patients with persistent knee pain 1 year or longer after total knee arthroplasty: a pilot study. Prim Care Companion CNS Disord. 2013;15(4):PCC.12m01496. doi: 10.4088/PCC.12m01496. Epub 2013 Jul 11.

  PMID: 24392250 RESULT

MeSH Terms

Conditions

Pain; Osteoarthritis

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations include this was a small open label pilot study.

Results Point of Contact

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

d.marks@duke.edu

619 668-2859

Study Officials

• Davi M Marks, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 6, 2015
• Results First Posted: May 23, 2014

Record last verified: 2015-01

Locations

US (1)