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Neuromultivit

Phase 3

Vertebrogenic Radiculopathy L5, S1 | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: May 9, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02508805Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic RadiculopathyPHASE3 COMPLETED 100May 1, 2015Nov 1, 2015May 9, 20171 Russia
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Study Endpoints
Primary Endpoints
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
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 Endpoints
Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire
baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale
baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale
baseline and 3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Neuromultivit +Voltaren+SirdaludEXPERIMENTALNeuromultivit 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.
Voltaren+Sirdalud aloneACTIVE_COMPARATORVoltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
Interventions
NameTypeDescription
NeuromultivitDRUG -
VoltarenDRUG -
SirdaludDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:Russia
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