Trial Outcomes & Findings for Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy (NCT NCT02607254)
NCT ID: NCT02607254
Last Updated: 2018-10-04
Results Overview
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Results posted on
2018-10-04
Participant Flow
11 subjects were recruited in the study.
Each subject underwent a washout period to stop the the current pain medications. Subjects who had significant reduction in pain were randomized to either placebo or Lyrica during the double blind withdrawal phase.
Participant milestones
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
Patients in this arm were initially treated with pregabalin in a single blind fashion. After 8 weeks of treatment, they were randomized to continue on pregabalin for 4 weeks in the double blind randomized withdrawal phase as their pain was improved per protocol.
|
Pregabalin Treatment/ Placebo Withdrawal
After finishing the pregabalin single-blinded treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase for 4 weeks as their pain was improved during treatment phase.
|
Pregabalin Treatment/No Withdrwal
These patients were treated with Pregabalin, but did not qualify for withdrawal phase as their pain did not improve to meet the criteria to enter the withdrawal phase.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Baseline characteristics by cohort
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
n=3 Participants
All patients will were with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
|
Pregabalin Treatment/ Placebo Withdrawal
n=3 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
|
Pregabalin Treatment/ No Withdrawal
n=5 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients did not qualify to continue to withdrawal phase.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phasePopulation: Patient with idiopathic small fiber neuropathy.
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
Outcome measures
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
n=3 Participants
All patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
|
Pregabalin Treatment/ Placebo Withdrawal
n=3 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
|
Pregabalin Treatment/No Withdrwal
n=5 Participants
After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase.
|
|---|---|---|---|
|
Visual Analogue Score for Pain Intensity.
Basline
|
7.1 score on visual analogue score
Standard Deviation 1.4
|
6.9 score on visual analogue score
Standard Deviation 1.7
|
7.3 score on visual analogue score
Standard Deviation 2.3
|
|
Visual Analogue Score for Pain Intensity.
After 8 weeks of Pregabalin
|
5.4 score on visual analogue score
Standard Deviation 0.8
|
5.1 score on visual analogue score
Standard Deviation 1.1
|
7.6 score on visual analogue score
Standard Deviation 2.9
|
|
Visual Analogue Score for Pain Intensity.
After 4 weeks of Withdrawal phase
|
6.1 score on visual analogue score
Standard Deviation 1.2
|
7.4 score on visual analogue score
Standard Deviation 1.8
|
NA score on visual analogue score
Standard Deviation NA
Patients did not qualify for the withdrawal phase.
|
SECONDARY outcome
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phasePopulation: Patients with idiopathic small fiber neuropathy.
Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.
Outcome measures
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
n=3 Participants
All patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
|
Pregabalin Treatment/ Placebo Withdrawal
n=3 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
|
Pregabalin Treatment/No Withdrwal
n=5 Participants
After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI sf);
Basline
|
6.7 score in brief pain inventory scale
Standard Deviation 0.9
|
6.3 score in brief pain inventory scale
Standard Deviation 1.1
|
7.2 score in brief pain inventory scale
Standard Deviation 1.3
|
|
Brief Pain Inventory (BPI sf);
After 8 weeks of Pregabalin
|
4.9 score in brief pain inventory scale
Standard Deviation 1.1
|
4.5 score in brief pain inventory scale
Standard Deviation 1.4
|
6.8 score in brief pain inventory scale
Standard Deviation 1.7
|
|
Brief Pain Inventory (BPI sf);
After 4 weeks of Withdrawal phase
|
5.8 score in brief pain inventory scale
Standard Deviation 2.1
|
5.6 score in brief pain inventory scale
Standard Deviation 1.9
|
NA score in brief pain inventory scale
Standard Deviation NA
These patients did not qualify for withdrawal phase.
|
SECONDARY outcome
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phasePopulation: Patients with idiopathic small fiber neuropathy
a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.
Outcome measures
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
n=3 Participants
All patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
|
Pregabalin Treatment/ Placebo Withdrawal
n=3 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
|
Pregabalin Treatment/No Withdrwal
n=5 Participants
After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase.
|
|---|---|---|---|
|
Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);
Basline
|
4.5 score on Sleep Interference Rating scale
Standard Deviation 0.3
|
5.3 score on Sleep Interference Rating scale
Standard Deviation 0.61
|
5.9 score on Sleep Interference Rating scale
Standard Deviation 0.7
|
|
Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);
After 8 weeks of Pregabalin
|
3.1 score on Sleep Interference Rating scale
Standard Deviation 0.65
|
2.8 score on Sleep Interference Rating scale
Standard Deviation 1.1
|
5.1 score on Sleep Interference Rating scale
Standard Deviation 1.5
|
|
Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);
After 4 weeks of Withdrawal phase
|
3.9 score on Sleep Interference Rating scale
Standard Deviation 0.71
|
4.3 score on Sleep Interference Rating scale
Standard Deviation 0.87
|
NA score on Sleep Interference Rating scale
Standard Deviation NA
These patients did not qualify for the withdrawal phase.
|
SECONDARY outcome
Timeframe: At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phasePopulation: Patients with idiopathic small fiber neuropathy
patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.
Outcome measures
| Measure |
Pregabalin Treatment/Pregabalin Withdrawal
n=3 Participants
All patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
|
Pregabalin Treatment/ Placebo Withdrawal
n=3 Participants
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
|
Pregabalin Treatment/No Withdrwal
n=5 Participants
After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC);
After Withdrawal phase
|
3.9 score on PGIC scale
Standard Deviation 0.7
|
4.2 score on PGIC scale
Standard Deviation 1.11
|
NA score on PGIC scale
Standard Deviation NA
These patients did not qualify for the withdrawal phase.
|
|
Patient Global Impression of Change (PGIC);
After 8 weeks of pregabalin
|
4.1 score on PGIC scale
Standard Deviation 0.31
|
5.4 score on PGIC scale
Standard Deviation .61
|
1.8 score on PGIC scale
Standard Deviation 0.34
|
Adverse Events
Pregabalin Treatment/Pregabalin Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregabalin Treatment/ Placebo Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregabalin Treatment/No Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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