Multiple sclerosis MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Trileptal
Product Name: Oxcarbazepine
Pharmaceutical Form:
INN or Proposed INN: oxcarbazepine
Other descriptive name: Trilep
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of definite multiple sclerosis 2. Treatment with DMDs for MS for at least 6 months prior to baseline visit*. 3. CSF NFL level = 0.380ng/mL 4. EDSS score =3.5 and = 6.0 at screening 5. No history of relapses in the 6 months prior to the baseline visit 6. A history of slow progression of disability, objective or subjective, over a period of at least 6 months prior to baseline 7. Age 18-60 years at screening * 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding or unwilling to use adequate contraception*. 2. Participants with a diagnosis of primary progressive PP MS or primary relapsing PR MS. 3. A clinical relapse or pulsed intravenous/ oral steroids for MS relapse in the 6 months preceding the baseline assessment. 4. 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. 5. Infection with hepatitis B or hepatitis C or human immunodeficiency virus. 6. Exposure to any other investigational drug within 30 days of enrolment in the study. 7. 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). 8. Prior history of malignancy unless an exception is granted by the investigator. 9. History of uncontrolled drug or alcohol abuse within 6 months prior to screening. 10. Past untoward reactions to OxCbz or Cbz 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does oxcarbazepine protect people with multiple sclerosis (PwMS) from nerve loss? When we compare PwMS who take oxcarbazepine for one year to PwMS who take placebo, is the level of neurofilament light (NFL), a marker of nerve loss, in the CSF significantly reduced?; Secondary Objective: Can we detect reduction of nerve loss after 6 month of treatment with oxcarbazepine, as measured by lower levels of NFL in the CSF? Can we detect a change in conventional clinical outcome measure such as the EDSS, 9-hole peg test and the MSIS-29 v2 and neurocognitive tests such as single digit modalities test (SDMT) at the end of the study? Will will also use conventional and innovative imaging methods such as brain MRI scans and (optico-coherence tomography) OCT and will use CSF, serum and cells to analyse other markers of the effect of degeneration/neuroprotection. ;Primary end point(s): The primary objective is to assess whether OxCbz has a neuroprotective effect in participants with early SP or stable RRMS with history of progression, as measured by the stabilization or decrease of CSF NFL levels.;Timepoint(s) of evaluation of this end point: This endpoint is being evaluated from Baseline to 48 weeks post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change over 48 weeks of the study using clinical outcome measures: EDSS 30, and the Questionnaires (Including SF36, MSWS, MSIS-29 v2, Patient Pain Assessment, Patient Fatigue Assessment) and neurocognitive tests such as single digit modalities test (SDMT. Relative reduction of CSF NFL levels from baseline to 24 weeks and from 24 to 48 weeks. ;Timepoint(s) of evaluation of this end point: Timelines outlined above and baseline, 24 weeks and 48 weeks. | — |
Countries
United Kingdom
Contacts
Public ContactSally Burtles
Barts Health NHS Trust
Outcome results
None listed