The Effect of Levetiracetam (Keppra) on the Treatment of Tremor in Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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;

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle, Tyne and Wear, United Kingdom, NE1 4LP
      • Sir James Spence Institute, Royal Victoria Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with multiple sclerosis and clinical evidence of cerebellar tremor.

Description

Inclusion Criteria:

1. McDonald criteria for diagnosis of MS (McDonald, 2001)15
2. Clinical evidence of Cerebellar Tremor.
3. Aged 18-60

Exclusion Criteria:

1. There is evidence of a further significant MS relapse during the trial
2. Evidence of resting tremor, or Holmes (rubral) tremor
3. Pregnant or breast feeding mothers
4. Patients with inadequate understanding of the English language to comprehend the patient information sheet
5. Evidence of any significant renal impairment
6. History of epilepsy

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Dr P Nichols, MRCP, DPhil, Newcastle NHS Hospitals Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: February 1, 2007
• First Submitted That Met QC Criteria: February 1, 2007
• First Posted (ESTIMATE): February 2, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 3384