Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Valeant Russia, LLC
• Treatments: Clonidine; Diclofenac; Tizanidine

Criteria

Inclusion Criteria:

• diagnosed vertebrogenic radiculopathy L5, S1

• radicular pain syndrome

• changes in the low back CT and MRI scans

• minimum 40 mm intensity of spontaneous back pain, rated on the VA scale

• 1 month exacerbation phase; nonuse of any B-group vitamins before the trial

• negative urine pregnancy test; Patient Informed Consent

Exclusion Criteria:

• tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy

• concomitant life-threatening medical conditions

• simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases

• epilepsy, alcohol and drug addiction

• pregnancy and breast-feeding

• any condition preventing CT and MRI tests, including obesity and special devices

• participation in any other clinical study 1 month before enrollment.