Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy (NMRUS)

Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy

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.

Study Overview

• Status: Completed
• Conditions: Vertebrogenic Radiculopathy L5, S1
• Intervention / Treatment: Drug: Neuromultivit; Drug: Voltaren; Drug: Sirdalud

Detailed Description

Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days.

Group 2 (50 patients) receive only standard therapy for 20 days.

Standard therapy involves:

• Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days
• Sirdalud (2 mg tablets three times a day) for 20 days

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Republic of Tatarstan
    • Kazan, Republic of Tatarstan, Russian Federation, 420021
      • State Autonomous Institution Republican Clinical Centre of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromultivit +Voltaren+Sirdalud; Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days. Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days.	Drug: Neuromultivit; Drug: Voltaren; Drug: Sirdalud
Active Comparator: Voltaren+Sirdalud alone; Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days	Drug: Voltaren; Drug: Sirdalud

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale	Self reported pain intensity over the last 24 hours. The amount of pain is marked on a horizontal line at a certain point which reflects pain perception best: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).	baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire	Self reported quality and intensity of pain, described by selecting 7 words, which reflect pain perception best, from 20 groups: three words from groups 1-10, two words from groups 11-15, a single word from group 16, one word from groups 17-20.	baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale	Self reported effect of pain on body functions and daily activities. The scores of responses to 19 questions (6 multiple choice questions and 13 single choice questions) are summed, yielding a total between 0 and 100 with higher values representing greater disability.	baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale	Self reported pain related functional limitations to 20 activities. The degree of difficulty in performing these daily activities is scored from 0-5 (0 = no effort, 5 = not able to), yielding a total between 0 and 100 with higher values representing greater disability.	baseline and 3 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Systolic Blood Pressure at 10 Days	baseline and 10 days
Change from Baseline in Systolic Blood Pressure at 3 weeks	baseline and 3 weeks
Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks	baseline and 3 weeks
Change from Baseline in Full Blood Count at 3 weeks	baseline and 3 weeks
Change from Baseline in Urine Test at 3 weeks	baseline and 3 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Collaborators: Valeant Russia, LLC
• Investigators: Principal Investigator: Farit Khabirov, MD, DSc, Prof, State Autonomous Institution Republican Clinical Centre of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diclofenac; Tizanidine
• Other Study ID Numbers: NM-01RUS; 224 (registration study)