Clinical trial NCT05639946: Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Official title: Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Injured for \&gt; 3 months
* Completed inpatient rehabilitation and living in the community
* Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
* For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).

Exclusion Criteria:

* Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
* Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
* Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
* Pregnancy or lactation
* Epilepsy or active treatment for seizure disorder
* Past or current suicidality
* Active treatment for psychiatric disease
* Drug addiction
* Moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week)
* Hepatic cirrhosis, Child-Pugh grades A, B, and C
* Impaired renal function (GFR\&lt;60ml/minute)
* Contraindications to brivaracetam or pyrrolidine derivatives including allergy
* Active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
* History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of brivaracetam
* Use of any investigational drug 30 days prior to enrollment in this study
* Enrollment in another clinical trial.

Primary outcomes:
measure: change in pain intensity
timeFrame: 3 months
measure: change in operculum brain connectivity
timeFrame: 3 months
measure: microRNA-485 levels
timeFrame: baseline
measure: microRNA-485 levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ricardo Battaglino, PhD
role: PRINCIPAL_INVESTIGATOR
References: