Multiple Sclerosis Clinical Trial
Official title:
Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
The histaminergic system is phylogenetically one of the oldest parts of the nervous system but it is a relatively recent discovery. It is involved with several vegetative functions like sleep, attention and learning, feeding and satiety, working memory, cognition, depression, and most of all arousal and energy
1. Establish in an open label clinical trial the tolerability and safety of various doses
of l-histidine and lodosyn that may increase levels of l-histidine and histamine in the
serum and cerebrospinal fluid (CSF).
2. Perform pharmacokinetic studies in serum and CSF of study subjects the levels of
l-histidine and histamine after treatment with various combination of l-histidine and
lodosyn.
3. Preliminary information will also be collected on the effects of this intervention on
alleviation of fatigue.
The findings from this study go beyond the effects of histamine on fatigue. If central
histamine can be increased by the strategy outlined above, a number of other vegetative
hypothalamic functions intricately associated with fatigue including sleep, cognition and
satiety need to be examined in MS patients in future studies.
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