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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-001776-13-DE |
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Date of registration:
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26/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Levetiracetam in the treatment of spasticity in MS: a ranomized double blind cross over study
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Scientific title:
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Efficacy of Levetiracetam in the treatment of spasticity in MS: a ranomized double blind cross over study |
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Date of first enrolment:
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05/08/2005 |
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Target sample size:
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24 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001776-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
clinical definite MS
mild to medium spasticity
Penn score at least 1
minimum age 18
informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
known intolerance towards Levetiracetam
EDSS score > 6.5
pregnant or breast feading women
severe renal and liver impairment
other severe conditions
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Product Name: Levetiracetam
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): improvement of spasticity scores
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Main Objective: Reduction of spasticity measrued in clinical scores (Ashworth an Penn scale)
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Secondary Objective: qualitiy of life
safety
side effects
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Secondary ID(s)
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2005-MS-LEV-1
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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