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| ID | Type | Description | Link |
|---|---|---|---|
| SAV-MD-08 |
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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.
The current study proposes to collect pilot data on the utility of open-label milnacipran for the treatment of pain and other outcomes in this unfortunate group of patients with chronic persistent pain after TKA. Among marketed serotonin norepinephrine reuptake inhibitors (SNRIs), milnacipran has a unique property in that it blocks serotonin and norepinephrine reuptake equally. It is plausible that equipotent reuptake inhibition may confer greater analgesic benefit compared to other agents, and in preclinical animal models milnacipran has shown superior effects of ameliorating hyperalgesia and allodynia compared to some other antidepressant drugs. Additionally, milnacipran does not have inhibitory effects on cytochrome P (CYP) 450 enzymes, no binding affinity to neurotransmitter receptors liable to cause adverse events, and simple pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milnacipran | Experimental | Open-label flexibly dosed milnacipran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label flexibly dosed milnacipran | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Society Score (KSS). | KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks. KSS 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davi M Marks, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24392250 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran | Open-label flexibly dosed milnacipran |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 patients enrolled, 4 completed, 1 terminated due to adverse event.
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| ID | Title | Description |
|---|---|---|
| BG000 | Milnacipran | Open-label flexibly dosed milnacipran |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and endpoint 12 weeks |
|
12 weeks between baseline visit and week 12 visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milnacipran | Open-label flexibly dosed milnacipran |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | physician defined | Non-systematic Assessment | Spontaneously reported |
Limitations include this was a small open label pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Marks, MD | Duke University Medical Center | 619 668-2859 | d.marks@duke.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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) | Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue. Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported | Baseline to endpoint (12 weeks or early termination) |
| Change in the Beck Depression Inventory (BDI-II) | The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression. | Baseline to endpoint (12 weeks or early termination) |
| Change in the Montgomery Asberg Depression Rating Scale | Staff-rated assessment of depressive symptoms. Scale is as follows: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression | Between baseline and endpoint (12 weeks or early termination) |
| Change in Total Score of State Trait Anxiety Inventory (STAI) | Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported. | baseline and endpoint (12 weeks or early termination) |
| Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life | Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The eight sections are:
Scale: 0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported. | baseline and endpoint (12 weeks or early termination) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Knee Society Score (KSS). | KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks. KSS 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. | Posted | Mean | Standard Deviation | units on a scale | between baseline and endpoint (12 weeks or early termination) |
|
|
|
| Secondary | Global Rating of Change | Data not collected. | Posted | Endpoint (12 weeks or early termination) |
|
|
| Secondary | Change in Total Score of Multidimensional Fatigue Inventory (MFI-20) | Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue. Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported | Posted | Mean | Standard Deviation | units on a scale | Baseline to endpoint (12 weeks or early termination) |
|
|
|
| Secondary | Change in the Beck Depression Inventory (BDI-II) | The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline to endpoint (12 weeks or early termination) |
|
|
|
| Secondary | Change in the Montgomery Asberg Depression Rating Scale | Staff-rated assessment of depressive symptoms. Scale is as follows: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression | Posted | Mean | Standard Deviation | units on a scale | Between baseline and endpoint (12 weeks or early termination) |
|
|
|
| Secondary | Change in Total Score of State Trait Anxiety Inventory (STAI) | Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported. | Posted | Mean | Standard Deviation | units on a scale | baseline and endpoint (12 weeks or early termination) |
|
|
|
| Secondary | Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life | Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The eight sections are:
Scale: 0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported. | Posted | Mean | Standard Deviation | units on a scale | baseline and endpoint (12 weeks or early termination) |
|
|
|
| 0 |
| 5 |
| 4 |
| 5 |
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| Headache | General disorders | physician defined | Non-systematic Assessment | Spontaneously reported |
|
| constipation | Gastrointestinal disorders | physician defined | Non-systematic Assessment | Spontaneously reported |
|
| painful ejaculation | Nervous system disorders | physician defined | Non-systematic Assessment | Spontaneously reported |
|
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| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |