NCT02104661.

Study name	Protective Role of Oxcarbazepine in Multiple Sclerosis (PROXIMUS)
Methods	RCT
Participants	Inclusion Criteria: A diagnosis of definite multiple sclerosis Treatment with DMDs for at least 6 months EDSS score between 3.5 and 6.0 No history of relapses in the preceding 6 months A history of slow progression of disability, objective or subjective, over a period of at least 6 months Age 18 to 60 years Exclusion Criteria: Pregnant or breastfeeding or unwilling to use adequate contraception. Participants who do not take a DMDs for MS. A clinical relapse or pulsed intravenous or oral steroids in the 6 months preceding the baseline assessment. Participants presenting with medical disorder deemed severe or unstable by the CI such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (>2.5 times ULN) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count <500, neutrophil count <1.5 or platelet count <100, or thrombocytopenia <1.5 LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the participant. Infection with hepatitis B or hepatitis C or human immunodeficiency virus. Participants receiving other sodium or calcium channel blockers in the previous 12 weeks Exposure to any other investigational drug within 30 days of enrolment in the study. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide‐Severity Rating Scale (CSSRS). Prior history of malignancy unless an exception is granted by the Chief Investigator. History of uncontrolled drug or alcohol abuse within 6 months prior to enrolment into the study. Past untoward reactions to OxCbz or CBZ
Interventions	Experimental: Oxcarbazepine Treatment Treated for 48 weeks with OxCarbazepine 150mg twice a day alongside current DMDs. Placebo Comparator: Oxcarbazepine Placebo Treated for 48 weeks with matched placebo 1 tablet twice a day alongside current DMDs.
Outcomes	Primary Outcome Measures: Relative reduction of CSF neurofilament light chain levels Secondary Outcome Measures: Safety of Oxcarbazepine Relative reduction of CSF neurofilament levels Change in clinical outcome measured by neurological examination Change in clinical outcome measured by cognitive assessment  Change in patient reported outcomes measured by questionnaires Others
Starting date	Not yet recruiting
Contact information	Monica Calado Marta    m.calado-marta@qmul.ac.uk
Notes	ClinicalTrials.gov identifier: NCT02104661

RCT: randomised controlled trial

DMD: Disease‐modifying drugs

MS: Multiple Sclerosis

SPMS: secondary progressive MS

EDSS: Expanded Disability Status Score

MRI: Magnetic Resonance Imaging