Clinical trial NCT04764383: Histaminergic Basis of Fatigue in Multiple Sclerosis
Official title: Histaminergic Basis of Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Fatigue
Histamine
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blind randomized cross-over
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to identify a way to improve the feeling of exhaustion that patients might experience because of Multiple Sclerosis (MS).


Eligibility criteria: Inclusion and Exclusion Criteria

For Healthy (Normal) Participants

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Inclusion Criteria:

* 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)
* Fatigue Severity Score of \>/= 4.0 will qualify as long as all other inclusion/exclusion criteria is met.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Efficacy as measured by FSS scores
timeFrame: Up to 5 weeks
measure: Efficacy as measured by MFIS Scores
timeFrame: Up to 5 weeks
measure: Efficacy as measured by the VAS scores
timeFrame: Up to 5 weeks
measure: Efficacy as measured by the MSQOL Scores
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Kottil Rammohan, MD
role: PRINCIPAL_INVESTIGATOR
References: