Status:
COMPLETED
Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
Lead Sponsor:
University of Miami
Collaborating Sponsors:
United States Department of Defense
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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, attenti...
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 cerebrospina...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Healthy Volunteers:
- Male or female subjects between the ages of 18 and 60 will be eligible.
- Subjects should be in good physical health without history of chronic illness and should be generally considered healthy.
- Spouses or caregivers of patients with MS would be encouraged to participate.
- Inclusion Criteria for Patients with Multiple Sclerosis (MS):
- Patients with MS regardless of the disease type, who experience severe fatigue will be eligible to participate.
- Fatigue Severity Score of \>/= 4.0 will qualify as long as all other inclusion / exclusion criteria are met.
- Established MS by McDonald Criteria - 2010 Revision (24). Relapse Remitting (RR) and progressive forms of MS are eligible
- Severe fatigue that has lasted greater than 6 months
- Clinically stable on a current therapy with any Disease Modifying Therapy (DMT)
- Exclusion Criteria for Healthy Volunteers:
- Adults unable to give informed consent due to cognitive impairment or mental disorders.
- Children below the age of consent
- Pregnant women
- Prisoners
- History of chronic disorders like hypertension, diabetes, hyperlipidemia, depression, hypothyroidism etc. that require chronic treatment
- Known chronic fatigue syndrome
- Blood disorders or coagulopathy
- Chronic allergies or history of asthma.
- Using antihistamines, bronchodilators or H2 blockers for hyperacidity
- Using medications for sleep, or known sleep disorders
- Any medication or condition deemed unsuitable by the PI
- Exclusion Criteria for Patients with Multiple Sclerosis (MS):
- Adults unable to give informed consent due to cognitive impairment or mental disorders.
- Children below the age of consent
- Pregnant women
- Prisoners
- Systemic disorders known to cause fatigue such as severe anemia, infections, chronic systemic infectious or inflammatory disorders, including known autoimmune disorders.
- Chronic fatigue syndrome
- Hypothyroidism
- Systemic malignancy
- Undergoing chemotherapy
- Depression
- Sleep disorders including narcolepsy, excessive day-time sleep.
- History of substance abuse
- Excessive consumption of coffee or over-the-counter stimulants
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03266965
Start Date
March 23 2018
End Date
August 7 2020
Last Update
October 8 2020
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136