The Effect of Levetiracetam (Keppra) on the Treatment of Tremor in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

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 (~ 90,000 patients'
      affected). It has been estimated that the direct cost to the National Health Service is over
      £300 million/year and the total cost to UK society exceeds £1.3 billion/year. 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;
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with multiple sclerosis and clinical evidence of cerebellar tremor.