NCT03266965

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-23
• Primary completion: 2020-08-07
• Completion: 2020-08-07
• First posted: 2017-08-30
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study