Trial Outcomes & Findings for Effect of Milnacipran in Chronic Neuropathic Low Back Pain (NCT NCT01225068)
NCT ID: NCT01225068
Last Updated: 2014-01-17
Results Overview
Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation. This is the primary outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 weeks from baseline
Results posted on
2014-01-17
Participant Flow
Outpatient clinic
Screening visit prior to randomization
Participant milestones
| Measure |
Milnacipran
Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
Placebo
Placebo treatment group
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Baseline characteristics by cohort
| Measure |
Milnacipran
n=20 Participants
Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
Placebo
n=20 Participants
Placebo treatment group
|
Total
n=40 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
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
48.3 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks from baselinePopulation: per protocol
Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation. This is the primary outcome measure.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo arm
|
Milnacipran
n=16 Participants
Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
|---|---|---|
|
Effect Size of VAS Pain
|
24.8 units on a scale
Standard Deviation 32.5
|
31.3 units on a scale
Standard Deviation 26.4
|
Adverse Events
Milnacipran
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Milnacipran
n=20 participants at risk
Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
Placebo
n=20 participants at risk
Placebo treatment group
|
|---|---|---|
|
Gastrointestinal disorders
colon resection
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
Other adverse events
| Measure |
Milnacipran
n=20 participants at risk
Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
Placebo
n=20 participants at risk
Placebo treatment group
|
|---|---|---|
|
General disorders
headache
|
10.0%
2/20 • Number of events 2 • baseline to 8 weeks after randomization
|
35.0%
7/20 • Number of events 7 • baseline to 8 weeks after randomization
|
|
Gastrointestinal disorders
nausea
|
25.0%
5/20 • Number of events 5 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
|
Nervous system disorders
dizziness
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
15.0%
3/20 • Number of events 3 • baseline to 8 weeks after randomization
|
|
Gastrointestinal disorders
constipation
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
10.0%
2/20 • Number of events 2 • baseline to 8 weeks after randomization
|
|
Skin and subcutaneous tissue disorders
itching
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
|
General disorders
drowsiness
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
|
Gastrointestinal disorders
abdominal pain
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
|
Reproductive system and breast disorders
sexual dysfunction
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
|
General disorders
fatigue
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
|
Gastrointestinal disorders
dry mouth
|
15.0%
3/20 • Number of events 3 • baseline to 8 weeks after randomization
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
|
Renal and urinary disorders
urinary frequency
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
|
General disorders
insomnia
|
0.00%
0/20 • baseline to 8 weeks after randomization
|
5.0%
1/20 • Number of events 1 • baseline to 8 weeks after randomization
|
Additional Information
Thomas J Schnitzer
Northwestern University Feinberg School of Medicine
Phone: 3125032315
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place