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NCT05639946 · ClinicalTrials.gov registry record · Phase 3
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT05639946: Completed Phase 3 study, sponsored by University of Minnesota.
NCT05639946 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05639946, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain.
Primary Outcome
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Average Worst Neuropathic Pain Intensity assesses the average worst neuropathic pain intensity in the last week using a 0-10 numerical rating scale where higher scores represent greater pain intensity. Change in pain intensity will be evaluated by comparing baseline intensity with 7-week post intervention intensity.
Interventions
- DRUG Placebo
- DRUG brivaracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2024-10-16 |
| Phase | Phase 3 |
What the finished NCT05639946 record still lists
NCT05639946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05639946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05639946 about?
NCT05639946 is a clinical study titled "Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial". Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-re...
What is the current status of trial NCT05639946?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2023-01-01. Estimated completion is 2024-10-16.
What interventions are being tested in trial NCT05639946?
The interventions under investigation include: Placebo (DRUG), brivaracetam (DRUG).
Who is sponsoring clinical trial NCT05639946?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05639946's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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