Trial Outcomes & Findings for Pregabalin in CIPN (NCT NCT02394951)
NCT ID: NCT02394951
Last Updated: 2019-05-14
Results Overview
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline to week 4
Results posted on
2019-05-14
Participant Flow
Participant milestones
| Measure |
Pregabalin First Then Placebo
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo First Then Pregabalin
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Period I
STARTED
|
12
|
14
|
|
Period I
COMPLETED
|
11
|
13
|
|
Period I
NOT COMPLETED
|
1
|
1
|
|
Period II
STARTED
|
11
|
13
|
|
Period II
COMPLETED
|
11
|
9
|
|
Period II
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pregabalin in CIPN
Baseline characteristics by cohort
| Measure |
Pregabalin First Then Placebo
n=12 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo First Then Pregabalin
n=14 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 4Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
Outcome measures
| Measure |
Pregabalin
n=23 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=23 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
|
-0.0179 Pearson correlation coefficient
Interval -0.0459 to 0.0101
|
-0.0172 Pearson correlation coefficient
Interval -0.0514 to 0.017
|
SECONDARY outcome
Timeframe: Baseline to week 4Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
|
-1.0 units on a scale (0-10 NRS)
Standard Deviation 1.13
|
0.3 units on a scale (0-10 NRS)
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline to week 4Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Change in NPSI Outcomes
|
-9.8 units on a scale (0-100 NPSI score)
Standard Deviation 12.49
|
1.8 units on a scale (0-100 NPSI score)
Standard Deviation 20.93
|
SECONDARY outcome
Timeframe: Baseline to week 4Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Change in BPI Outcomes (SEVERITY)
|
-0.8 units on a scale (0-10 BPI severity)
Standard Deviation 1.52
|
-0.1 units on a scale (0-10 BPI severity)
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline to week 4Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Change in Sleep Problem Index (SPI) Outcomes
|
-5.1 units on a scale (0-100 SPI)
Standard Deviation 9.45
|
-4.1 units on a scale (0-100 SPI)
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: baseline to week 4Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Change in BPI Outcomes (INTERFERENCE)
|
-0.6 units on a scale (0-10 BPI interference)
Standard Deviation 1.64
|
-0.2 units on a scale (0-10 BPI interference)
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline to week 4Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
Outcome measures
| Measure |
Pregabalin
n=24 Participants
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=24 Participants
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Number of Patients With Significant Pain Reduction
|
5 Participants
|
3 Participants
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=25 participants at risk
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=25 participants at risk
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Gastrointestinal disorders
Small bowel obstruction
|
4.0%
1/25 • Number of events 1 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
0.00%
0/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
Other adverse events
| Measure |
Pregabalin
n=25 participants at risk
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
Placebo
n=25 participants at risk
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Pregabalin: Anticonvulsant
Placebo: Identical, matching inactive substance
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
68.0%
17/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
16.0%
4/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Nervous system disorders
Somnolence
|
88.0%
22/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
44.0%
11/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Gastrointestinal disorders
Dry Mouth
|
56.0%
14/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
40.0%
10/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
General disorders
Edema
|
32.0%
8/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
32.0%
8/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Investigations
Weight Gain
|
16.0%
4/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
4.0%
1/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Nervous system disorders
Headache
|
40.0%
10/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
44.0%
11/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
28.0%
7/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Eye disorders
Blurred Vision
|
32.0%
8/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
16.0%
4/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
General disorders
Gait Disturbance
|
8.0%
2/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
0.00%
0/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Nervous system disorders
Spasticity
|
12.0%
3/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
0.00%
0/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.0%
2/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
4.0%
1/25 • 11 weeks
Common Terminology Criteria for Adverse Events - CTCAE version 4.0
|
Additional Information
Dr. Simon Haroutounian
Washington University in Saint Louis
Phone: 3143622628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place