Spinal Cord Injuries
Conditions
Brief summary
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.
Detailed description
The investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. Baseline periaqueductal gray hyperactivity and microRNA levels will be measured as potential biomarkers of response to treatment. These preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in SCI.
Interventions
DRUGBrivaracetam
Escalating brivaracetam dose to 150 mg twice daily for 3 months
OTHERPlacebo
Placebo twice daily for 3 months
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spinal cord injury (SCI) * Participants must have completed inpatient rehabilitation and are living in the community * Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10) * Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial
Exclusion criteria
* Pprogressive myelopathy secondary to posttraumatic cord tethering * Syringomyelia * Brain injury limiting the ability to follow directions * Pregnancy or lactation * Epilepsy * Impaired liver or renal function * Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory, Worst Pain | baseline | 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. |
| Brief Pain Inventory, Least Pain | baseline | 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. |
| Brief Pain Inventory, Average Pain | baseline | 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. |
| Satisfaction With Life Scale (SWLS) | baseline | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Participants in this arm will receive a placebo.
Placebo: Placebo twice daily for 3 months | 9 |
| Brivaracetam Group Participants in this arm will receive the investigational drug, Brivaracetam.
Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Brivaracetam Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 12.5 | 47.10 years STANDARD_DEVIATION 11.2 | 51.6 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 8 / 9 | 11 / 11 |
| serious Total, serious adverse events | 0 / 9 | 1 / 11 |
Outcome results
Primary
Brief Pain Inventory, Average Pain
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Average Pain | 6.7 score on scale | Standard Deviation 1.8 |
| Brivaracetam Group | Brief Pain Inventory, Average Pain | 7.5 score on scale | Standard Deviation 1.6 |
Primary
Brief Pain Inventory, Average Pain
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Average Pain | 6.4 score on scale | Standard Deviation 1.9 |
| Brivaracetam Group | Brief Pain Inventory, Average Pain | 7 score on scale | Standard Deviation 1.8 |
Primary
Brief Pain Inventory, Least Pain
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Least Pain | 5.1 score on scale | Standard Deviation 3.3 |
| Brivaracetam Group | Brief Pain Inventory, Least Pain | 4.8 score on scale | Standard Deviation 3.2 |
Primary
Brief Pain Inventory, Least Pain
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Least Pain | 5.6 score on scale | Standard Deviation 2.4 |
| Brivaracetam Group | Brief Pain Inventory, Least Pain | 4.7 score on scale | Standard Deviation 3.4 |
Primary
Brief Pain Inventory, Worst Pain
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Worst Pain | 8.9 score on scale | Standard Deviation 1 |
| Brivaracetam Group | Brief Pain Inventory, Worst Pain | 9.7 score on scale | Standard Deviation 0.8 |
Primary
Brief Pain Inventory, Worst Pain
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Brief Pain Inventory, Worst Pain | 8.1 score on scale | Standard Deviation 1.6 |
| Brivaracetam Group | Brief Pain Inventory, Worst Pain | 7.8 score on scale | Standard Deviation 1.7 |
Primary
Satisfaction With Life Scale (SWLS)
The 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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Satisfaction With Life Scale (SWLS) | 17.9 score on a scale | Standard Deviation 7 |
| Brivaracetam Group | Satisfaction With Life Scale (SWLS) | 20.2 score on a scale | Standard Deviation 5.6 |
Primary
Satisfaction With Life Scale (SWLS)
The 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Satisfaction With Life Scale (SWLS) | 18.3 score on a scale | Standard Deviation 8.4 |
| Brivaracetam Group | Satisfaction With Life Scale (SWLS) | 19.8 score on a scale | Standard Deviation 8.1 |