Protective Role of Oxcarbazepine in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02104661
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Queen Mary University of London
• Public title: Protective Role of Oxcarbazepine in Multiple Sclerosis PROXIMUS
• Scientific title: OxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a Trial
• Date of first enrolment: October 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02104661
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Monica Calado Marta
• Affiliation: Barts & The London NHS Trust

• Name: Gavin Givannoni
• Affiliation: Queen Mary University of London

Key inclusion & exclusion criteria

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 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.]

Exclusion Criteria:

- 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.]



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: Oxcarbazepine

Primary Outcome(s)

Relative reduction of CSF neurofilament light chain levels [Time Frame: From baseline to week 48]

Secondary Outcome(s)

Safety of Oxcarbazepine in multiple sclerosis patients [Time Frame: Ongoing throughout the trial]

Change in clinical outcome measured by cognitive assessment [Time Frame: Baseline, week 12, 24, 36 and 48]

Change in patient reported outcomes measured by questionnaires [Time Frame: Baseline, weeks 12, 24, 36 and 48]

Change in clinical outcome measured by neurological examination. [Time Frame: Baseline, week 24 and week 48]

Relative reduction of CSF neurofilament levels [Time Frame: baseline, 24 weeks and 48 weeks]

Secondary ID(s)

2013-002419-87

8722

14-LO-0185

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Barts & The London NHS Trust

Southend University Hospital

Basildon and Thurrock University Hospitals NHS Foundation Trust

Barnet and Chase Farm Hospitals NHS Trust

National Multiple Sclerosis Society

Royal Free Hospital NHS Foundation Trust

University College, London

Novartis Pharmaceuticals

St George's Healthcare NHS Trust