Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430599
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2007-02-01
Brief Title:
The Effect of Levetiracetam Keppra on the Treatment of Tremor in Multiple Sclerosis
Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Organization:
Newcastle-upon-Tyne Hospitals NHS Trust
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-10
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:
We are carrying out this study to determine whether Keppra a drug usually used to treat epilepsy is an effective treatment for tremor in patients with Multiple Sclerosis Tremor is one of the most common symptoms in MS but also one of the most difficult to treat A very small previous study has indicated that Keppra may be effective in this role but we need to reproduce these results in many more patients before we can reliably confirm this
Detailed Description:
Multiple Sclerosis is the most common inflammatory demyelinating disease of the CNS and is the leading cause of neurological disability in young adults in the UK 90000 patients affected It has been estimated that the direct cost to the National Health Service is over 300 millionyear and the total cost to UK society exceeds 13 billionyear The personal cost in terms of disability is also high with 50 of patients requiring aids to walk or being wheelchair bound within 16 years of disease onset Recently attention has focused on disease modifying drugs including b-Interferon which have demonstrated a significant reduction in clinical relapse rate associated with a dramatic reduction in disease activity on brain MRI4-7 However the evidence for any sustained long term benefit is poor Therefore symptomatic therapies remain a key part of patient management
Cerebellar tremor and cerebellar gait instability are present in up to 70 of chronic MS patients and account for a significant amount of clinical morbidity Cerebellar tremor is a major therapeutic problem in MS since currently there are no effective treatments To date medical therapies including propranolol clonazepam carbamazepine isoniazid phenobarbitone ondansetron topiramate gabapentin and cannabis have all been studied with little sustained benefit More radical surgical treatments including thalamotomy and Deep Brain Stimulation have also been attempted
However a recent pilot study with a small number of patients suggested that Keppra Levetiracetam is effective in treating MS tremor This study relied upon a rather subjective assessment of tremor and did not assess patients using quantitative physiological measures
This protocol involves a collaboration between a clinical neurologist with a recognised expertise in MS and a research group with an established expertise in the electrophysiological and pharmacological investigation of human tremor11 The protocol describes a study in MS patients designed to establish whether Keppra Levetiracetam produces
1 Physiologically measurable reduction in tremor
2 Subjective and qualitative reduction in tremor
Cerebellar tremor and cerebellar gait instability are present in up to 70 of chronic MS patients and account for a significant amount of clinical morbidity Cerebellar tremor is a major therapeutic problem in MS since currently there are no effective treatments To date medical therapies including propranolol clonazepam carbamazepine isoniazid phenobarbitone ondansetron topiramate gabapentin and cannabis have all been studied with little sustained benefit More radical surgical treatments including thalamotomy and Deep Brain Stimulation have also been attempted
However a recent pilot study with a small number of patients suggested that Keppra Levetiracetam is effective in treating MS tremor This study relied upon a rather subjective assessment of tremor and did not assess patients using quantitative physiological measures
This protocol involves a collaboration between a clinical neurologist with a recognised expertise in MS and a research group with an established expertise in the electrophysiological and pharmacological investigation of human tremor11 The protocol describes a study in MS patients designed to establish whether Keppra Levetiracetam produces
1 Physiologically measurable reduction in tremor
2 Subjective and qualitative reduction in tremor
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