Clinical trial NCT02508805: Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
Official title: Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vertebrogenic Radiculopathy L5, S1
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Valeant Russia, LLC
First posted: 2015-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
timeFrame: baseline and 3 weeks
Secondary outcomes:
measure: Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire
timeFrame: baseline and 3 weeks
measure: Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale
timeFrame: baseline and 3 weeks
measure: Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale
timeFrame: baseline and 3 weeks
Other outcomes:
measure: Change from Baseline in Systolic Blood Pressure at 10 Days
timeFrame: baseline and 10 days
measure: Change from Baseline in Systolic Blood Pressure at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from Baseline in Full Blood Count at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from Baseline in Urine Test at 3 weeks
timeFrame: baseline and 3 weeks
Locations:
city: Kazan
country: Russian Federation
facility: State Autonomous Institution Republican Clinical Centre of Neurology
state: Republic of Tatarstan
Study officials:
affiliation: State Autonomous Institution Republican Clinical Centre of Neurology
name: Farit Khabirov, MD, DSc, Prof
role: PRINCIPAL_INVESTIGATOR
References: