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

• ClinicalTrials.gov Identifier: NCT02508805
• Recruitment Status: Completed
• First Posted: July 27, 2015
• Last Update Posted: May 9, 2017
• Sponsor: Bausch Health Americas, Inc.
• Collaborator: Valeant Russia, LLC
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Vertebrogenic Radiculopathy L5, S1	Drug: Neuromultivit; Drug: Voltaren; Drug: Sirdalud	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale [ Time Frame: baseline and 3 weeks ]
   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).

Secondary Outcome Measures :

1. Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire [ Time Frame: baseline and 3 weeks ]
   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.
2. Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale [ Time Frame: baseline and 3 weeks ]
   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.
3. Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale [ Time Frame: baseline and 3 weeks ]
   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.

Other Outcome Measures:

1. Change from Baseline in Systolic Blood Pressure at 10 Days [ Time Frame: baseline and 10 days ]
2. Change from Baseline in Systolic Blood Pressure at 3 weeks [ Time Frame: baseline and 3 weeks ]
3. Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks [ Time Frame: baseline and 3 weeks ]
4. Change from Baseline in Full Blood Count at 3 weeks [ Time Frame: baseline and 3 weeks ]
5. Change from Baseline in Urine Test at 3 weeks [ Time Frame: baseline and 3 weeks ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Russian Federation

State Autonomous Institution Republican Clinical Centre of Neurology

Kazan, Republic of Tatarstan, Russian Federation, 420021

Sponsors and Collaborators

Bausch Health Americas, Inc.

Valeant Russia, LLC

Investigators

• Principal Investigator: Farit Khabirov, MD, DSc, Prof; State Autonomous Institution Republican Clinical Centre of Neurology

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02508805
• Other Study ID Numbers: NM-01RUS; 224 ( Registry Identifier: registration study )
• First Posted: July 27, 2015
• Last Update Posted: May 9, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Radiculopathy; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diclofenac; Tizanidine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticonvulsants; Muscle Relaxants, Central; Neuromuscular Agents; Parasympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents