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Neuromultivit

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Neuromultivit · 1 trial · 1 indication

Phase 3 1
NCT02508805Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic RadiculopathyVertebrogenic Radiculopathy L5, S1
COMPLETED100 Analytics
PHASE3COMPLETED
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
Vertebrogenic Radiculopathy L5, S1Unlock trial analytics

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 to 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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Frequently asked questions about Neuromultivit

What is Neuromultivit used for?

Neuromultivit is an investigational small molecule being studied for the treatment of vertebrogenic radiculopathy affecting the L5 and S1 nerve roots. It is in Phase 3 clinical development for this neurological condition.

Who makes Neuromultivit?

Neuromultivit is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with vertebrogenic radiculopathy.

What phase is Neuromultivit in?

Neuromultivit is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed to assess its effects in vertebrogenic radiculopathy.

What clinical trials is Neuromultivit in?

Neuromultivit has one completed Phase 3 trial, NCT02508805, titled 'Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy.' The trial enrolled 100 participants in Russia and was active-controlled, though not double-blinded.

Is Neuromultivit the same as any other drug?

Neuromultivit is a distinct drug candidate developed by Bausch Health. No alternative names have been reported for this investigational therapy in the context of its clinical development for vertebrogenic radiculopathy.