NCT00430599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

First QC Date

February 1, 2007

Last Update Submit

October 7, 2015

Conditions

Multiple Sclerosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with multiple sclerosis and clinical evidence of cerebellar tremor.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir James Spence Institute, Royal Victoria Infirmary

Newcastle, Tyne and Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dr P Nichols, MRCP, DPhil

    Newcastle NHS Hospitals Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

February 1, 2007

Study Completion

September 1, 2009

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

GB(1)