drugset / Trial / NCT03106740
Evaluating the Role of Neuroinflammation in Low Back Pain
Phase 2
Completed
60 enrolled
Marco Loggia
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.
Timeline
- Start
- 2017-10-10
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Minocycline Arm vs Placebo Arm; p = 0.956; NCT03106740 ↗
paper The mean thalamic positron emission tomography standard uptake value ratio was very stable across visits in both groups, with no significant group-by-time interaction (P = 0.956). PMID 40839604 ↗
Publications
- Background Loggia ML, Chonde DB, Akeju O, Arabasz G, Catana C, Edwards RR, Hill E, Hsu S, Izquierdo-Garcia D, Ji RR, Riley M, Wasan AD, Zurcher NR, Albrecht DS, Vangel MG, Rosen BR, Napadow V, Hooker JM. Evidence for brain glial activation in chronic pain patients. Brain. 2015 Mar;138(Pt 3):604-15. doi: 10.1093/brain/awu377. Epub 2015 Jan 12.
- Background Vanelderen P, Van Zundert J, Kozicz T, Puylaert M, De Vooght P, Mestrum R, Heylen R, Roubos E, Vissers K. Effect of minocycline on lumbar radicular neuropathic pain: a randomized, placebo-controlled, double-blind clinical trial with amitriptyline as a comparator. Anesthesiology. 2015 Feb;122(2):399-406. doi: 10.1097/ALN.0000000000000508.
- Mohammadian M, Morrissey EJ, Knight PC, Brusaferri L, Kim M, Efthimiou N, Murphy JP, Alshelh Z, Grmek G, Schnieders JH, Chane CA, Sandstrom A, Catana C, Gilman JM, Locascio JJ, Edwards RR, Zhang Y, Napadow V, Loggia ML. Investigating the potential of minocycline in reducing brain inflammation in chronic low back pain: a randomized, placebo-controlled mechanistic clinical trial. Pain. 2025 Apr 9;166(9):2044-2053. doi: 10.1097/j.pain.0000000000003543.
- Morrissey EJ, Alshelh Z, Knight PC, Saha A, Kim M, Torrado-Carvajal A, Zhang Y, Edwards RR, Pike C, Locascio JJ, Napadow V, Loggia ML. Assessing the potential anti-neuroinflammatory effect of minocycline in chronic low back pain: Protocol for a randomized, double-blind, placebo-controlled trial. Contemp Clin Trials. 2023 Mar;126:107087. doi: 10.1016/j.cct.2023.107087. Epub 2023 Jan 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Minocycline | Small molecule | 100 mg | Oral |