Trial Outcomes & Findings for Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury (NCT NCT04379011)
NCT ID: NCT04379011
Last Updated: 2025-10-14
Results Overview
The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
COMPLETED
PHASE1/PHASE2
24 participants
baseline
2025-10-14
Participant Flow
Participant milestones
| Measure |
Control Group
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Control Group
n=9 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=11 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
43.5 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
47.10 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baselineThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Worst Pain
|
8.9 score on scale
Standard Deviation 1
|
9.7 score on scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 3 monthsThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Worst Pain
|
8.1 score on scale
Standard Deviation 1.6
|
7.8 score on scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: baselineThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Least Pain
|
5.1 score on scale
Standard Deviation 3.3
|
4.8 score on scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 3 monthsThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Least Pain
|
5.6 score on scale
Standard Deviation 2.4
|
4.7 score on scale
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: baselineThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Average Pain
|
6.7 score on scale
Standard Deviation 1.8
|
7.5 score on scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 3 monthsThe Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Brief Pain Inventory, Average Pain
|
6.4 score on scale
Standard Deviation 1.9
|
7 score on scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: baselineThe satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Satisfaction With Life Scale (SWLS)
|
17.9 score on a scale
Standard Deviation 7
|
20.2 score on a scale
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: 3 monthsThe satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=6 Participants
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Satisfaction With Life Scale (SWLS)
|
18.3 score on a scale
Standard Deviation 8.4
|
19.8 score on a scale
Standard Deviation 8.1
|
Adverse Events
Control Group
Brivaracetam Group
Serious adverse events
| Measure |
Control Group
n=9 participants at risk
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=11 participants at risk
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
General disorders
hospitalization due to nausea and vomiting
|
0.00%
0/9 • 2 years
|
9.1%
1/11 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Control Group
n=9 participants at risk
Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months
|
Brivaracetam Group
n=11 participants at risk
Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal symptoms
|
0.00%
0/9 • 2 years
|
45.5%
5/11 • Number of events 9 • 2 years
|
|
Nervous system disorders
neurological symptoms
|
33.3%
3/9 • Number of events 3 • 2 years
|
45.5%
5/11 • Number of events 6 • 2 years
|
|
General disorders
fatigue
|
22.2%
2/9 • Number of events 2 • 2 years
|
45.5%
5/11 • Number of events 5 • 2 years
|
|
General disorders
psychological symptoms
|
22.2%
2/9 • Number of events 2 • 2 years
|
27.3%
3/11 • Number of events 3 • 2 years
|
|
General disorders
vasomotor symptoms
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/11 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place