Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Miami
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Male or female subjects between the ages of 18 and 60
In good physical health without a history of chronic illness and considered generally healthy.
Established Multiple Sclerosis by McDonald Criteria - 2010 Revision or McDonald Criteria 2017. Relapsing-Remitting 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 Therapies (DMT)
You may not be if
For Healthy (Normal) Participants
Adults unable to give informed consent due to cognitive impairment or mental disorders.
Children below the age of consent
Pregnant women (if the pregnancy test is positive during any stage of the study, subject will be removed from it)
Prisoners
Chronic untreated disorders like hypertension, diabetes, hyperlipidemia, depression, hypothyroidism etc., that could confound or interfere with the proposed therapy in the view of the PI are excluded. Stable treated above conditions are not exclusionary.
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. If necessary, subjects should wash out such medications for a duration of at least 5 half-lives.
All medications prescribed and over the counter, should be approved by the PI during the duration of the trial.
For Multiple Sclerosis Participants
Adults unable to give informed consent due to cognitive impairment or mental disorders.
Children below the age of consent
Pregnant women (if the pregnancy test is positive during any stage of the study, subject will be removed from it)
Prisoners
Systemic disorders known to cause fatigue such as severe anemia, infections, chronic systemic infectious or inflammatory disorders, including known autoimmune disorders. (allowed as long is not present. Subject might qualify as per discretion of the Principal Investigator)
Chronic fatigue syndrome
Hypothyroidism (If treated and/or controlled subject might qualify as per discretion of the Principal Investigator)
Systemic malignancy. Remote history of a malignancy is not a contraindication.
Undergoing chemotherapy
Depression (If treated and/or controlled subject might qualify as per discretion of the Principal Investigator)
Sleep disorders including narcolepsy, excessive day-time sleep. (If treated and/or controlled subject might qualify as per discretion of the Principal Investigator)
Ongoing substance abuse
Excessive consumption of coffee or over-the-counter stimulants. Use of caffeine is not exclusionary but subjects are instructed to not change the use for the duration of the study.
Concomitant medications of amantadine, methylphenidate, amphetamines, pemoline, barbiturates, tizanidine, MonoAmine Oxidase (MAO) inhibitors, benzodiazepines, barbiturates, tricyclic antidepressants, antihistamines, H2 blockers for Gastroesophageal reflux disease (GERD), Selective Serotonin Reuptake Inhibitor (SSRIs) and any other medication that in the opinion of the PI should be excluded. If used and approved by the PI at study entry, any change for the duration of the study is not permitted.
Patients who were using modafinil for treatment of fatigues prior to the study may participate but will be required to undergo a washout of five half-lives prior to entry into the trial.
Clareo Health | Histaminergic Basis of Fatigue in Multiple Sclerosis
