Protective Role of Oxcarbazepine in Multiple Sclerosis

NCT02104661 | Completed Phase 2 DMC

• 3 other identifiers: 87222013-002419-8714-LO-0185
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

People with multiple sclerosis (MS) have nerve loss even without acute inflammatory relapses, as obvious in the progressive phase of disease. Drugs that may prevent nerve loss work better in earlier stages when it is difficult to measure progressive disability. But it is now possible to measure the nerve loss as neurofilament light (NFL) in the cerebrospinal fluid (CSF). This is a trial of a neuroprotective drug, oxcarbazepine, which showed benefit in an animal model of multiple sclerosis. The investigators will use an innovative outcome, a reduction in the content of NFL in the CSF, as well as the usual clinical disability and imaging methods, to measure the success of the oxcarbazepine as a neuroprotective agent in MS. The use of NFL, a surrogate marker of neurodegeneration, allows a blinded and accurate outcome.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Relative reduction of CSF neurofilament light chain levels

  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.

  From baseline to week 48

Secondary Outcomes (5)

• 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

• Change in clinical outcome measured by cognitive assessment

  Baseline, week 12, 24, 36 and 48

• Change in patient reported outcomes measured by questionnaires

  Baseline, weeks 12, 24, 36 and 48

Other Outcomes (3)

• MRI scan to measure neurodegeneration

  Baseline and week 48

• OCT to measure retinal nerve fibre layer (RNFL) for neurodegeneration

  Baseline and weeks 24 and 48

• Biological samples collected to test for biomarkers of MS and correlation with response to OxCbz as a neuroprotector

  Baseline, week 12, 24, 36 and 48

Study Arms (2)

OxCarbazepine Treatment

EXPERIMENTAL

Treated for 48 weeks with OxCarbazepine 150mg twice a day alongside current DMDs.

Drug: Oxcarbazepine

OxCarbazepine Placebo

PLACEBO COMPARATOR

Treated for 48 weeks with matched placebo 1 tablet twice a day alongside current DMDs

Drug: Placebo

Interventions

Oxcarbazepine DRUG

Oxcarbazepine 150mg tablet, over encapsulated and back-filled with Microcrystalline Cellulose/Magnesium Stearate 1%.

Also known as: Trileptal

OxCarbazepine Treatment

Placebo DRUG

Placebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%.

OxCarbazepine Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 of disability, objective or subjective, over a period of at least 6 months prior to baseline
• Age 18-60 years
• \[Temporary interruption is permitted at the discretion of the investigator for a period of up to 8 weeks to prevent inflammatory MS reactivation. The cases where this could happen include for example switching DMDs that require a washout period as per clinical practice. When there are safety concerns, as in Lymphopenia or other side effects induced by the DMD, the interruption period can exceed 8 weeks as per clinical need. If reactivation of MS occurs with a relapse the investigator will assess if this meets withdrawal criteria 6.\]

You may not qualify if:

• Pregnant or breastfeeding or unwilling to use adequate contraception.\*
• Participants with a diagnosis of primary progressive PP MS or primary relapsing PR 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 investigator, would pose additional risk to the participant.
• Infection with hepatitis B or hepatitis C or human immunodeficiency virus.
• 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 Investigator.
• History of uncontrolled drug or alcohol abuse within 6 months prior to screening.
• Past untoward reactions to OxCbz or Cbz
• Participants receiving OxCbz or Cbz in the previous 12 weeks from baseline
• \[Adequate methods of contraception are non hormonal methods such as barrier methods, intrauterine devices, surgical sterilisation (undergone by the participant or their partner). Female participants using hormonal only forms of contraception will be required to use an additional barrier method. True abstinence can be considered an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception. Non sexually active participants or those in same sex relationships will not be required to commence contraception.\]

Sponsors & Collaborators

• Queen Mary University of London: lead
• National Multiple Sclerosis Society: collaborator
• Novartis Pharmaceuticals: collaborator
• Barts & The London NHS Trust: collaborator
• University College, London: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• St George's Healthcare NHS Trust: collaborator
• Barnet and Chase Farm Hospitals NHS Trust: collaborator

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

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MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gavin Givannoni

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Monica Calado Marta

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: October 1, 2014
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)