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Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639946
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neuropathic Pain Drug: brivaracetam Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
Participants with severe neuropathic pain will receive brivaracetam treatment
 Drug: brivaracetam
Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 2 weeks, followed by 50mg TID for 2 weeks, followed by 100mg BID for 48 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain.
Placebo Comparator: Control group
Participants with severe neuropathic pain will receive placebo drug
 Drug: Placebo
Participants will receive placebo drug


Outcome Measures
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Primary Outcome Measures :
  1. change in pain intensity [ Time Frame: 3 months ]
    the International Spinal Cord Injury Pain Data Set

  2. change in operculum brain connectivity [ Time Frame: 3 months ]
    assess changes in cortical activity of related pain perception regions and networks in the brain in response to brivaracetam treatment compared to placebo using rsfMRI and pain- related task-based fMRI.

  3. microRNA-485 levels [ Time Frame: baseline ]
    use Next-Generation sequencing to assess miR-485 levels

  4. microRNA-485 levels [ Time Frame: 3 months ]
    use Next-Generation sequencing to assess miR-485 levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Injured for > 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<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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05639946


Contacts
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Contact: Angela Philippus 612-625-2661 phili272@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ricardo Battaglino,, PhD    612-625-2661    rbattagl@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Ricardo Battaglino, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05639946    
Other Study ID Numbers: Brivaracetam
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Brivaracetam
Anticonvulsants