Clinical Trial

Histaminergic Basis of Central Fatigue in Multiple Sclerosis

Study Description

Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach

Specific Aims: 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Carbidopa

All subjects will receive a fixed dose of 50mg of Lodosyn twice daily.

Dietary Supplement - L-Histidine

Sequential Dose Escalation of 250mg to 500mg to 1000mg twice daily.

Additional Information

Official Study Title

Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach

Clinical Trial ID

NCT03266965

ParticipAid ID

Ddw4Je