Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257855
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2005-11-22
Brief Title:
A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis
Sponsor:
University College London Hospitals
Organization:
University College London Hospitals
Study Overview
Official Title:
A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis Single Centre Phase 2 Trial
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A present there is no safe treatment for reducing rate at which disability worsens in people with secondary progressive multiple sclerosis Recent research has suggested the possibility that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres in the brain and spinal cord In this trial the investigators will test whether one such drug called lamotrigine can prevent damage to nerve fibres and reduce the rate at which MS worsens The period of treatment in the trial will run for 2 years
Detailed Description:
At present there is no safe widely applicable treatment that is capable of reducing the rate at which disability advances in secondary progressive multiple sclerosis SPMS There is good evidence that the primary cause of disability is axonal degeneration within the CNS so there is considerable interest in developing treatments which can protect axons from degeneration Experimental work by members of our group has established that axons may degenerate upon exposure to the inflammatory mediator nitric oxide The mechanism of the damage implies that protection might be afforded by the novel approach of partially blocking sodium channels and our group and others have recently demonstrated that drugs including flecainide phenytoin and lamotrigine can reduce axonal degeneration when optic nerves or spinal roots are exposed to nitric oxide and in experimental autoimmune encephalomyelitis
Aims To assess whether the sodium channel blocker lamotrigine has a neuroprotective disease modifying effect on a the rate of axonal degeneration and b the accumulation of disability in patients with SPMS
Methodology We propose to recruit 120 people with SPMS in whom progression rather than relapse is the major cause of increasing disability into a double blind parallel group controlled trial lasting two years in which random allocation would be made to receive treatment with either lamotrigine or placebo We anticipate that patient recruitment follow-up and trial management could be achieved readily across four proposed sites in London The primary endpoint would be an effect of treatment on cerebral atrophy which correlates with other MR markers of axonal loss and which can be measured reliably and sensitively using recently developed MR techniques The trial is powered to detect a 60 beneficial effect on the rate of development of cerebral atrophy Secondary endpoints would include effects of treatment on spinal cord atrophy and on clinical measurements of impairmentdisability MR measures of brain volume and cervical spinal cord cross-sectional area and scores of clinical impairmentdisability would be determined at entry and then after 12 and 24 months Brain volume would be measured additionally at 6 and 18 months Clinical follow-up would occur every 3 months and interim analysis is planned at 12 months
Utilization of results A phase 2 trial of sodium channel blockade in SPMS is timely given recent advances arising from experimental and imaging work A successful outcome would enable sufficiently powered phase 3 trials to be implemented but perhaps more significantly would demonstrate a novel safe neuroprotective strategy to reduce long-term disability in this disorder
Aims To assess whether the sodium channel blocker lamotrigine has a neuroprotective disease modifying effect on a the rate of axonal degeneration and b the accumulation of disability in patients with SPMS
Methodology We propose to recruit 120 people with SPMS in whom progression rather than relapse is the major cause of increasing disability into a double blind parallel group controlled trial lasting two years in which random allocation would be made to receive treatment with either lamotrigine or placebo We anticipate that patient recruitment follow-up and trial management could be achieved readily across four proposed sites in London The primary endpoint would be an effect of treatment on cerebral atrophy which correlates with other MR markers of axonal loss and which can be measured reliably and sensitively using recently developed MR techniques The trial is powered to detect a 60 beneficial effect on the rate of development of cerebral atrophy Secondary endpoints would include effects of treatment on spinal cord atrophy and on clinical measurements of impairmentdisability MR measures of brain volume and cervical spinal cord cross-sectional area and scores of clinical impairmentdisability would be determined at entry and then after 12 and 24 months Brain volume would be measured additionally at 6 and 18 months Clinical follow-up would occur every 3 months and interim analysis is planned at 12 months
Utilization of results A phase 2 trial of sodium channel blockade in SPMS is timely given recent advances arising from experimental and imaging work A successful outcome would enable sufficiently powered phase 3 trials to be implemented but perhaps more significantly would demonstrate a novel safe neuroprotective strategy to reduce long-term disability in this disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None