Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379011
• Other study ID #: Morse
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Injuries

Intervention

Drug:
• Brivaracetam
Escalating brivaracetam dose to 150 mg twice daily for 3 months

Other:
• Placebo
Placebo twice daily for 3 months

Locations

Country	Name	City	State
United States	Swedish Hospital	Englewood	Colorado
United States	University of Minnesota School of Medicine	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	miRNA in Treatment Group	Outcome reported as the mean number of copies of the target miRNA at baseline.	baseline
Primary	Change in Brief Pain Inventory	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.	baseline, 3 months
Primary	Change in 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.	baseline, 3 months
Secondary	Change in Periaqueductal Gray Activity	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.	baseline, 3 months