NCT02644421

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

Phase Ib Randomized, Double-Blind, Latin Square Crossover, Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 v. Lidocaine v. Placebo in Lumbar Radiculopathy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiculopathy
• Sciatica

Interventions

Type	Name	Description
DRUG	VVZ-149
DRUG	Lidocaine
DRUG	Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-12-31
• Last updated: 2018-03-19

Locations

1 site across 1 country: United States