Trial Outcomes & Findings for Milnacipran for Lumbosacral Radicular Pain (NCT NCT01777581)
NCT ID: NCT01777581
Last Updated: 2014-07-23
Results Overview
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.
COMPLETED
PHASE4
13 participants
baseline and 10 weeks
2014-07-23
Participant Flow
Participant milestones
| Measure |
Milnacipran
Milnacipran, flexibly dosed
|
Sugar Pill (Placebo)
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Milnacipran
Milnacipran, flexibly dosed
|
Sugar Pill (Placebo)
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Milnacipran for Lumbosacral Radicular Pain
Baseline characteristics by cohort
| Measure |
Milnacipran
n=7 Participants
Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
|
Sugar Pill (Placebo)
n=4 Participants
Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
4 participants
n=4 Participants
|
11 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 10 weeksThe 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.
Outcome measures
| Measure |
Milnacipran
n=5 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=3 Participants
Placebo
|
|---|---|---|
|
Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)
Values at baseline
|
58.7 units on a scale
Standard Deviation 9.4
|
67.7 units on a scale
Standard Deviation 26.5
|
|
Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)
Values at endpoint
|
13.6 units on a scale
Standard Deviation 8.5
|
59.7 units on a scale
Standard Deviation 43.6
|
SECONDARY outcome
Timeframe: baseline and 10 weeksThe secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. 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 scores were reported
Outcome measures
| Measure |
Milnacipran
n=5 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=3 Participants
Placebo
|
|---|---|---|
|
VAS Related to Nociceptive Pain Component (VAS-Noc)
Values at baseline
|
57.3 units on a scale
Standard Deviation 17.2
|
64.7 units on a scale
Standard Deviation 43.0
|
|
VAS Related to Nociceptive Pain Component (VAS-Noc)
Values at endpoint
|
32.2 units on a scale
Standard Deviation 30.4
|
64.7 units on a scale
Standard Deviation 46.3
|
SECONDARY outcome
Timeframe: baseline and 10 weeksSelf-report of 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. Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Outcome measures
| Measure |
Milnacipran
n=5 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=3 Participants
Placebo
|
|---|---|---|
|
SF-36 (Short Form)
Values at baseline
|
96.9 units on a scale
Standard Deviation 6.3
|
101.3 units on a scale
Standard Deviation 4.0
|
|
SF-36 (Short Form)
Values at endpoint
|
97.0 units on a scale
Standard Deviation 5.8
|
99.7 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: baseline and 10 weeksSelf report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories: * Section 1 - Pain intensity * Section 2 - Personal care * Section 3 - Lifting * Section 4 - Walking * Section 5 - Sitting * Section 6 - Standing * Section 7 - Sleeping * Section 8 - Sex life (if applicable) * Section 9 - Social life * Section 10 - Travelling The scores are combined form each category into overall score. Scores are converted to percentages as follows: 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. 41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected. 61%-80%: crippled: Back pain impinges on all aspects of life. 81%-100%: Patients are either bed-bound or exaggerating their symptoms
Outcome measures
| Measure |
Milnacipran
n=5 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=3 Participants
Placebo
|
|---|---|---|
|
Oswestry Low Back Pain Disability Questionnaire
Values at baseline
|
20.1 percent score
Standard Deviation 7.4
|
22.8 percent score
Standard Deviation 11.2
|
|
Oswestry Low Back Pain Disability Questionnaire
Values at endpoint
|
18.1 percent score
Standard Deviation 8.0
|
22.5 percent score
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: baseline and 10 weeksSelf-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain. Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain.
Outcome measures
| Measure |
Milnacipran
n=7 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=4 Participants
Placebo
|
|---|---|---|
|
Neuropathic Pain Questionnaire
Values at baseline
|
415.1 units on a scale
Standard Deviation 202
|
601.4 units on a scale
Standard Deviation 336.7
|
|
Neuropathic Pain Questionnaire
Values at endpoint
|
238.3 units on a scale
Standard Deviation 279.9
|
511.3 units on a scale
Standard Deviation 414.1
|
SECONDARY outcome
Timeframe: baseline and 10 weeksSelf-report evaluation of depressive symptoms.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.
Outcome measures
| Measure |
Milnacipran
n=5 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=3 Participants
Placebo
|
|---|---|---|
|
Beck Depression Inventory (BDI-II)
Values at baseline
|
13.8 units on a scale
Standard Deviation 7.3
|
14.3 units on a scale
Standard Deviation 9.3
|
|
Beck Depression Inventory (BDI-II)
Values at endpoint
|
11.6 units on a scale
Standard Deviation 8.2
|
13.3 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: baseline and 10 weeksSelf-report evaluation of anxiety symptoms.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 Scale 1= almost never 4= almost always Higher scores indicate greater anxiety. Mean cumulative scores were reported
Outcome measures
| Measure |
Milnacipran
n=7 Participants
Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
|
Sugar Pill (Placebo)
n=4 Participants
Placebo
|
|---|---|---|
|
State-trait Anxiety Inventory (STAI)
Values at baseline
|
88.4 units on a scale
Standard Deviation 7.1
|
86.5 units on a scale
Standard Deviation 5.9
|
|
State-trait Anxiety Inventory (STAI)
Values at endpoint
|
90.0 units on a scale
Standard Deviation 7.9
|
84.0 units on a scale
Standard Deviation 10.9
|
Adverse Events
Milnacipran
Sugar Pill (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place