Radiculopathy Lumbar Clinical Trial
Official title:
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule. Part B will evaluate the analgesic efficacy of a single intravenous dose of LAT8881, compared with placebo, in patients with lumbar radicular pain. Healthy volunteers are not accepted for Part B.
Part A of this study is a double-blind, randomized, placebo-controlled, single ascending dose study of intravenous administration of LAT8881 over 5 minutes in healthy volunteers. Eight participants will be enrolled. Each participant has three treatment days, 1 infusion per dosing day, on Days 1, 4 and 7 as well as two short visits for safety blood sampling on Days 3 and 6. Participants are randomised, so on each treatment day, 6 participants receive LAT8881 and 2 receive placebo (different participants to receive placebo each treatment day). LAT8881 doses administered are 0.8 mg/kg on Day 1, 1.2 mg/kg on Day 4 and 1.8 mg/kg on Day 7. Part B of this study is is a placebo-controlled randomized double blind cross-over safety and efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain. Participants will be randomly assigned to one of two groups, to receive either LAT8881 then placebo or placebo then LAT8881. Participants will receive a either single dose of LAT8881 [the Maximum Tolerated Dose from Part A of the study] or placebo via intravenous administration over 5 minutes on two consecutive days. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05923736 -
Cardiovascular Risk in Digital Osteoarthritis
|
N/A | |
Completed |
NCT05003726 -
Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation
|
N/A | |
Completed |
NCT05556538 -
The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
|
||
Recruiting |
NCT06143813 -
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
|
N/A | |
Completed |
NCT04701879 -
Spinal Decompression Therapy in Radicular Chronic Low Back Pain
|
N/A | |
Active, not recruiting |
NCT05719792 -
Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections
|
||
Enrolling by invitation |
NCT06151704 -
The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation
|
N/A | |
Not yet recruiting |
NCT05793528 -
The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection
|
||
Not yet recruiting |
NCT06275529 -
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
|
N/A | |
Recruiting |
NCT05261581 -
Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy
|
Early Phase 1 | |
Completed |
NCT03894943 -
Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
|
N/A | |
Completed |
NCT05571046 -
Glucocorticoid Injection in Patients With Lumbar Radicular Pain
|
Phase 4 | |
Recruiting |
NCT04054401 -
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
|
N/A | |
Completed |
NCT04224077 -
Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)
|
N/A | |
Not yet recruiting |
NCT05729022 -
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
|
N/A | |
Terminated |
NCT03801356 -
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
|
Phase 4 | |
Recruiting |
NCT03502057 -
P-15L Bone Graft Lumbar Fusion Clinical Trial
|
N/A | |
Completed |
NCT04695912 -
The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back
|
N/A | |
Recruiting |
NCT06421558 -
Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
|
N/A | |
Completed |
NCT04276519 -
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
|
N/A |