Histaminergic Basis of Fatigue in Multiple Sclerosis
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
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).
Key facts
- Study ID
- NCT04764383
- Run by
- University of Miami
- People needed
- 0
- Starts
- 2022-01-01
- Expected to finish
- 2022-10-30
- Last updated by the study team
- 2021-07-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify 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.
You may not qualify if…
- 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
Where it is running
- University of Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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