Trial Outcomes & Findings for A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia (NCT NCT01173055)
NCT ID: NCT01173055
Last Updated: 2017-11-08
Results Overview
The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm\^2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Baselines measured at week 0 and week 9 after washout from first assignment to treatment
Results posted on
2017-11-08
Participant Flow
Participants enrolled in the study received placebo for 1 week (Day -7 to 0) then began the double blinded treatment sequence.
Participant milestones
| Measure |
Milnacipran First, Then Placebo
Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112).
|
Placebo First, Then Milnacipran
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112.
|
|---|---|---|
|
Period 1 - Day 1 to 49
STARTED
|
10
|
12
|
|
Period 1 - Day 1 to 49
COMPLETED
|
8
|
10
|
|
Period 1 - Day 1 to 49
NOT COMPLETED
|
2
|
2
|
|
Placebo Washout Period - Day 50 to 63
STARTED
|
8
|
10
|
|
Placebo Washout Period - Day 50 to 63
COMPLETED
|
8
|
10
|
|
Placebo Washout Period - Day 50 to 63
NOT COMPLETED
|
0
|
0
|
|
Period 2 - Day 64 to 112
STARTED
|
8
|
10
|
|
Period 2 - Day 64 to 112
COMPLETED
|
8
|
9
|
|
Period 2 - Day 64 to 112
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Milnacipran First, Then Placebo
Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112).
|
Placebo First, Then Milnacipran
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112.
|
|---|---|---|
|
Period 1 - Day 1 to 49
Withdrawal by Subject
|
2
|
2
|
|
Period 2 - Day 64 to 112
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Milnacipran First, Then Placebo
n=6 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo First, Then Milnacipran
n=9 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Fibromyalgia
|
46.83 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
36.67 years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
40.73 years
STANDARD_DEVIATION 10.187 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatmentThe primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm\^2.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Pain Threshold at Baseline
|
2.7333 kg/cm^2
Standard Deviation .83166
|
2.583 kg/cm^2
Standard Deviation .84339
|
PRIMARY outcome
Timeframe: baseline compared with 6 weeks of treatmentPopulation: Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.
The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm\^2. Lower values represent a worse outcome.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Change in Pain Threshold From Baseline to End of Treatment.
Pre-Treatment (Week 0 or 9)
|
2.7333 kg/cm^2
Standard Deviation .83166
|
2.583 kg/cm^2
Standard Deviation .84339
|
|
Change in Pain Threshold From Baseline to End of Treatment.
Post-Treatment (Week 6 or 15)
|
2.650 kg/cm^2
Standard Deviation 1.05982
|
2.70 kg/cm^2
Standard Deviation .99642
|
SECONDARY outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatmentPopulation: One participant did not complete this outcome measure.
0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=14 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.
|
8.134 units on a scale
Standard Deviation 17.51978
|
12.0240 units on a scale
Standard Deviation 20.80824
|
SECONDARY outcome
Timeframe: baseline compared with 6 weeks of treatmentPopulation: Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable. On the placebo, side one additional participant did not have data for this variable.
0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=14 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Pre-Treatment (Week 0 or 9)
|
8.134 units on a scale
Standard Deviation 17.51978
|
12.0240 units on a scale
Standard Deviation 20.80824
|
|
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Post-Treatment (Week 6 or 15)
|
11.0355 units on a scale
Standard Deviation 17.16822
|
8.50 units on a scale
Standard Deviation 19.6678
|
SECONDARY outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatmentThe primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Pain Tolerance at Baseline
|
4.2667 kg/cm^2
Standard Deviation 1.39983
|
3.80 kg/cm^2
Standard Deviation 1.17716
|
SECONDARY outcome
Timeframe: baseline compared wtih 6 weeks of treatmentPopulation: Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.
The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm\^2. Lower values represent a worse outcome.
Outcome measures
| Measure |
Milnacipran
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=15 Participants
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
|---|---|---|
|
Change in Pain Tolerance From Baseline to End of Treatment
Post-Treatment (Week 6 or 15)
|
3.8667 kg/cm^2
Standard Deviation 1.43261
|
3.8667 kg/cm^2
Standard Deviation 1.20218
|
|
Change in Pain Tolerance From Baseline to End of Treatment
Pre-Treatment (Week 0 or 9)
|
4.2667 kg/cm^2
Standard Deviation 1.39983
|
3.80 kg/cm^2
Standard Deviation 1.17716
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks laterOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks laterOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks laterOutcome measures
Outcome data not reported
Adverse Events
Milnacipran
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Milnacipran
n=20 participants at risk
Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=20 participants at risk
Placebo was given orally twice daily in tablet form at different times during the course of the study.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Herniated Disc
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
| Measure |
Milnacipran
n=20 participants at risk
Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
|
Placebo
n=20 participants at risk
Placebo was given orally twice daily in tablet form at different times during the course of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 5
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Dry Mouth
|
15.0%
3/20 • Number of events 3
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • Number of events 1
|
20.0%
4/20 • Number of events 4
|
|
Nervous system disorders
Distrubance in Attention
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
15.0%
3/20 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Increased Blood Pressure
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hot Flashes
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Sensitive to Light
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Eye disorders
Sore Eyes
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1
|
15.0%
3/20 • Number of events 3
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
Psychiatric disorders
Emotional
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Food Poisioning
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Cough/Congestion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Unable to Void
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Raw Tongue
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60