Status:
WITHDRAWN
Histaminergic Basis of Fatigue in Multiple Sclerosis
Lead Sponsor:
University of Miami
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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
- Inclusion and Exclusion Criteria
- For Healthy (Normal) Participants
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04764383
Start Date
January 1 2022
End Date
October 30 2022
Last Update
July 29 2021
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136