INTERVENTIONALCOMPLETEDNCT03266965

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-10-08

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 18 (ACTUAL)
Start date: 2018-03-23
Sponsor: University of Miami
Design: NA · SINGLE GROUP · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Multiple Sclerosis

Cannabinoids and active compounds

L-histidine

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Carbidopa

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

Lodosyn

DIETARY SUPPLEMENT

L-Histidine

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepted

Inclusion criteria

for Healthy Volunteers: 1. Male or female subjects between the ages of 18 and 60 will be eligible. 2. Subjects should be in good physical health without history of chronic illness and should be generally considered healthy. 3. Spouses or caregivers of patients with MS would be encouraged to participate.

Inclusion criteria

for Patients with Multiple Sclerosis (MS): 1. Patients with MS regardless of the disease type, who experience severe fatigue will be eligible to participate. 2. Fatigue Severity Score of \>/= 4.0 will qualify as long as all other inclusion /

Exclusion criteria

are met. 3. Established MS by McDonald Criteria - 2010 Revision (24). Relapse Remitting (RR) and progressive forms of MS are eligible 4. Severe fatigue that has lasted greater than 6 months 5. Clinically stable on a current therapy with any Disease Modifying Therapy (DMT)

Exclusion criteria

for Healthy Volunteers: 1. Adults unable to give informed consent due to cognitive impairment or mental disorders. 2. Children below the age of consent 3. Pregnant women 4. Prisoners 5. History of chronic disorders like hypertension, diabetes, hyperlipidemia, depression, hypothyroidism etc. that require chronic treatment 6. Known chronic fatigue syndrome 7. Blood disorders or coagulopathy 8. Chronic allergies or history of asthma. 9. Using antihistamines, bronchodilators or H2 blockers for hyperacidity 10. Using medications for sleep, or known sleep disorders 11. Any medication or condition deemed unsuitable by the PI

Exclusion criteria

for Patients with Multiple Sclerosis (MS): 1. Adults unable to give informed consent due to cognitive impairment or mental disorders. 2. Children below the age of consent 3. Pregnant women 4. Prisoners 5. Systemic disorders known to cause fatigue such as severe anemia, infections, chronic systemic infectious or inflammatory disorders, including known autoimmune disorders. 6. Chronic fatigue syndrome 7. Hypothyroidism 8. Systemic malignancy 9. Undergoing chemotherapy 10. Depression 11. Sleep disorders including narcolepsy, excessive day-time sleep. 12. History of substance abuse 13. Excessive consumption of coffee or over-the-counter stimulants 14. Concomitant medications of amantadine, methylphenidate, amphetamines, pemoline, barbiturates, tizanidine, Monoamine oxidase inhibitor (MAO) inhibitors, benzodiazepines, barbiturates, tricyclic antidepressants, antihistamines, H2 blockers for gastro-esophageal reflux disease (GERD), selective serotonin reuptake inhibitors (SSRIs) and any other medication that in the opinion of the PI should be excluded. 15. Patients who were using modafinil for treatment of fatigues prior to the study may participate but will be required to undergo a washout of 2 weeks prior to entry into the trial.

primary outcomes

primary measures

Number of adverse events experienced by participants.

Time frame: 30 days

All adverse and serious adverse events reported during the study will be analyzed and tabulated. No quantitative statistical analysis will be performed. The primary goal of this study is to establish that this intervention is safe and possibly effective.

secondary outcomes