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Oxcarbazepine

Phase 2

Multiple Sclerosis | Small molecule | Neurology |National Healthcare Corp.|Last Updated: Apr 18, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Oxcarbazepine · 1 trial · 1 indication

Phase 2 1
NCT02104661Protective Role of Oxcarbazepine in Multiple SclerosisMultiple Sclerosis
COMPLETED30 Analytics
PHASE2COMPLETED
Protective Role of Oxcarbazepine in Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative reduction of CSF neurofilament light chain levels
From baseline to week 48

CSF obtained from lumbar punctures will be used to determine neurofilament light chain levels from baseline to 48 weeks between the active and placebo treated arms.

Secondary Endpoints

Safety of Oxcarbazepine in multiple sclerosis patients
Ongoing throughout the trial
Relative reduction of CSF neurofilament levels
baseline, 24 weeks and 48 weeks
Change in clinical outcome measured by neurological examination.
Baseline, week 24 and week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OxCarbazepine TreatmentEXPERIMENTALTreated for 48 weeks with OxCarbazepine 150mg twice a day alongside current DMDs.
OxCarbazepine PlaceboPLACEBO_COMPARATORTreated for 48 weeks with matched placebo 1 tablet twice a day alongside current DMDs

Interventions

NameTypeDescription
OxcarbazepineDRUGOxcarbazepine 150mg tablet, over encapsulated and back-filled with Microcrystalline Cellulose/Magnesium Stearate 1%.
PlaceboDRUGPlacebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * A diagnosis of definite multiple sclerosis * Treatment with DMDs for at least 6 months prior to baseline visit\* * CSF NFL level ≥ 0.380ng/mL * EDSS score between 3.5 and 6.0 * No history of relapses in the 6 months prior to the baseline visit * A history of slow progression o...

Countries:United Kingdom
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Frequently asked questions about Oxcarbazepine

What is Oxcarbazepine used for in Multiple Sclerosis?

Oxcarbazepine is being studied for its protective role in Multiple Sclerosis. It is an investigational small molecule in Phase 2 clinical development for this condition. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial to assess its potential effects in patients with Multiple Sclerosis.

Who is developing Oxcarbazepine for Multiple Sclerosis?

Oxcarbazepine is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical research on this small molecule for the treatment of Multiple Sclerosis, a neurological condition. The drug is currently in Phase 2 development.

What phase is Oxcarbazepine in for Multiple Sclerosis?

Oxcarbazepine is in Phase 2 clinical development for Multiple Sclerosis. It is an investigational drug, not yet approved, and is being studied in a completed clinical trial. The trial was a randomized, double-blind, placebo-controlled study with 30 participants.

What clinical trials is Oxcarbazepine in for Multiple Sclerosis?

Oxcarbazepine has one completed clinical trial for Multiple Sclerosis, registered as NCT02104661, titled "Protective Role of Oxcarbazepine in Multiple Sclerosis." This Phase 2 study enrolled 30 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.

Is Oxcarbazepine FDA approved for Multiple Sclerosis?

Oxcarbazepine is not FDA approved for Multiple Sclerosis. It is an investigational drug currently in Phase 2 clinical development for this indication. The drug has completed one clinical trial, but it remains under investigation and has not received regulatory approval for this use.

What type of study was conducted for Oxcarbazepine in Multiple Sclerosis?

The clinical study for Oxcarbazepine in Multiple Sclerosis was a Phase 2, randomized, double-blind, placebo-controlled trial. It enrolled 30 adult participants in the United Kingdom and was biomarker-selected. The trial has been completed, and its results have not been disclosed.