drugset / Trial / NCT02644421

Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)

NCT02644421

Phase 1 Completed 18 enrolled Brigham and Women's Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (\>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.

Timeline

Start
2015-11
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 4 mg/kg Intravenous
Subject VVZ-149 Small molecule 1.3 mg/kg Intravenous

Indications