A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis

niversity College London0 sites120 target enrollmentJuly 4, 2005

Overview

No summary available.

Registry

who.int

Start Date

July 4, 2005

End Date

December 29, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity College London

•a) Age 18\-60 years. The lower limit has been chosen to enable informed consent, and the upper limit to avoid the possible inclusion of patients with cerebrovascular disease, which would potentially influence the cerebral volumes and white matter lesion numbers and thereby affect the MR outcome measures.
•b) Sex. Men and women will be included, but women of childbearing age would be required to use appropriate methods of contraception to avoid any teratogenic effects of lamotrigine.
•c) Patients with a diagnosis of secondary progressive MS where steady progression rather than relapse is the major cause of increased disability in the preceding 2 years, and who are therefore not eligible for treatment with disease modifying therapies according to the criteria of the Association of British Neurologists (available at www.theabn.org/downloads/msdoc.pdf) that are used as the current standard for practice in the UK National Health Service. Evidence of progression can be from either 1\) clinical documentation of steadily increasing disability, or 2\) an increase of at least 1 point in disability as measured using the EDSS.
•d) EDSS 4\.0\-6\.5\. Disability progresses at a relatively stable rate within this range of disability.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•a) Secondary progressive MS with very rapid deterioration of disability, if eligible for treatment with mitoxantrone at the National Hospital for Neurology and Neurosurgery using a protocol recently approved by the Trust’s Pharmaceutical Committee, making it unethical to offer an alternative, experimental treatment in a clinical trial.
•b) Use of sodium or calcium channel blockers in the previous 2 weeks, corticosteroids in the previous 2 months, or immunosuppressive drugs in the previous 6 months (12 months for mitoxantrone), as these have potential neuroprotective properties which may interact with the effects of lamotrigine and therefore dilute the power of the trial.
•c) Evidence of significant hepatic or renal abnormalities, either in the clinical history or in blood tests prior to entry into the trial. Patients with other major systemic diseases will also be excluded.
•d) Past untoward reactions to lamotrigine, or disabling temperature\-dependent symptoms related to MS, which may render participants vulnerable to side\-effects of lamotrigine.
•e) Contraindications to magnetic resonance imaging.