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

This study has been completed.
Sponsor:
Information provided by:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00430599
First received: February 1, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Phase
Multiple Sclerosis
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Enrollment: 20
Study Start Date: February 2007
Study Completion Date: September 2009
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;
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with multiple sclerosis and clinical evidence of cerebellar tremor.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430599

Locations
United Kingdom
Sir James Spence Institute, Royal Victoria Infirmary
Newcastle, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: Dr P Nichols, MRCP, DPhil Newcastle NHS Hospitals Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00430599     History of Changes
Other Study ID Numbers: 3384
Study First Received: February 1, 2007
Last Updated: September 17, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on August 27, 2014