Experimental clinical open study, randomized, experimental group vs co
Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta.
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Memantine
What it measured
Main measures
Percentage of reduction in whole brain volume. Percentage of reduction in regional brain volume. Number and volume of new T1 lesions black holes
MRI lesionsBrain volume loss
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
Inclusion: Onset of IFN-beta treatment within 3 months Diagnosis of clinically defined Multiple Sclerosis within 2 years according to McDonald s criteria Aged between 18 and 50 years EDSS 8804;3.5 Free from corticosteroids since at least 60 days, from immunosuppressors since at least 6 months and free of other immunomodulators since at least 2 months prior to enrollmentPatients willing to sign informed consent Patients with Beck Depression score 8804;10 Exclusion: Pregnant, breast-feeding women or those planning pregnancy Primary or secondary epilepsy Serious psychiatric pathologies Alcohol or drug abuse Serious systemic diseases with particular reference to endocrinopathies and metabolic diseases Brain trauma with sequels Depression evaluated according to Beck s scale score 10 Serious impairment and disablement that can interfere with performance of tests
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate treatment effects on MRI parameters more directly related to irreversible neurological damage; To evaluate the effects of the therapy on the cognitive sphere.
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History
- Status changed from Ongoing to Status unknown
- Result signal changed from Ongoing to Status unknown
Started
Apr 2007