Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT04379011|
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : February 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Drug: Brivaracetam Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Experimental: Brivaracetam Group
Participants in this arm will receive the investigational drug, Brivaracetam.
Escalating brivaracetam dose to 150 mg twice daily for 3 months
Other Name: Briviact
Placebo Comparator: Control Group
Participants in this arm will receive a placebo.
Placebo twice daily for 3 months
- Change in Brief Pain Inventory [ Time Frame: baseline, 3 months ]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.
- Change in Satisfaction with Life Scale (SWLS) [ Time Frame: baseline, 3 months ]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.
- Change in Periaqueductal Gray Activity [ Time Frame: baseline, 3 months ]Periaqueductal gray activity is measured by fMRI (functional magnetic resonance imaging). Outcome is reported as the change in bold signal (a unitless measure) in the targeted area.
- miRNA in Treatment Group [ Time Frame: baseline ]Outcome reported as the mean number of copies of the target miRNA at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379011
|Contact: Leslie Morse, DOemail@example.com|
|Contact: Nguyen Nguyen, MPHfirstname.lastname@example.org|
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|Contact: Scott Falci, MD email@example.com|
|Contact: Abigail Welch firstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota School of Medicine||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Leslie R Morse, DO 612-626-5957 email@example.com|
|Contact: Nguyen Nguyen, MPH firstname.lastname@example.org|
|Study Director:||Leslie Morse, DO||University of Minnesota|
|Principal Investigator:||Scott Falci, MD||Swedish Hospital|