Multiple SclerosisNCT00430599
The Effect of Levetiracetam (Keppra) on the Treatment of Tremor in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with multiple sclerosis and clinical evidence of cerebellar tremor.
Who may be able to join
- McDonald criteria for diagnosis of MS (McDonald, 2001)15
- Clinical evidence of Cerebellar Tremor.
- Aged 18-60
Who cannot join
- There is evidence of a further significant MS relapse during the trial
- Evidence of resting tremor, or Holmes (rubral) tremor
- Pregnant or breast feeding mothers
- Patients with inadequate understanding of the English language to comprehend the patient information sheet
- Evidence of any significant renal impairment
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir James Spence Institute, Royal Victoria Infirmary
Newcastle, Tyne and Wear, NE1 4LP
About this study
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.
Read the 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:
- Physiologically measurable reduction in tremor;
- Subjective and qualitative reduction in tremor;
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr P Nichols, MRCP, DPhil, Principal investigator, Newcastle NHS Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430599
- Sponsor's protocol ID
- 3384
- Status last verified
- Oct 2015
- First submitted
- 1 Feb 2007
- Last updated
- 12 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levetiracetam (Keppra) on the Treatment of Tremor in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00430599
- Acronym / sponsor ID
- 3384
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Physiologically measurable reduction in tremor;
- Subjective and qualitative reduction in tremor;
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with multiple sclerosis and clinical evidence of cerebellar tremor.
Key inclusion criteria (3 listed)
- McDonald criteria for diagnosis of MS (McDonald, 2001)15
- Clinical evidence of Cerebellar Tremor.
- Aged 18-60
Key exclusion criteria (6 listed)
- There is evidence of a further significant MS relapse during the trial
- Evidence of resting tremor, or Holmes (rubral) tremor
- Pregnant or breast feeding mothers
- Patients with inadequate understanding of the English language to comprehend the patient information sheet
- Evidence of any significant renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr P Nichols, MRCP, DPhil principal investigator
Newcastle NHS Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.