INTERVENTIONALWITHDRAWNNCT04764383
Histaminergic Basis of Fatigue in Multiple Sclerosis
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).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2021-07-29
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE2
- Enrollment
- 0 (ACTUAL)
- Start date
- 2022-01-01
- Sponsor
- University of Miami
- Design
- RANDOMIZED · CROSSOVER · TREATMENT
- Locations
- 1
- Results record
- Not present in registry snapshot
Multiple SclerosisFatigueHistamine
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGL-Histidine
1000 mg capsules taken by mouth (PO) twice daily (BID).
HistamineDRUGPlacebo
Microcrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID).
DRUGLodosyn
50 mg capsules taken PO BID.
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Accepted
Eligibility criteria
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/
primary outcomes
primary measures
Incidence of Adverse Events
Time frame: Up to 5 weeks
Adverse events will be evaluated by treating physician.
secondary outcomes
secondary measures
Efficacy as measured by FSS scores
Time frame: Up to 5 weeks
Efficacy will be reported as the number of participants that dropped one point or more from their baseline Fatigue Severity Scale (FSS) scores. FSS is a 9-item questionnaire with questions related to how fatigue interferes with certain activities according to a self-reported scale. Each of the items are scored on a 7 point scale with 1 = strongly disagree and 7 = strongly agree.
Efficacy as measured by MFIS Scores
Time frame: Up to 5 weeks
Modified Fatigue Impact Scale (MFIS) is a scale is used to measure fatigue with the total score ranging from 0 to 84 with 0 being the best possible score and 84 being the worst score.
Efficacy as measured by the VAS scores
Time frame: Up to 5 weeks
The Visual Analog Scale (VAS) allows participants to rate their health on a 20 cm vertical with a higher number indicating better outcomes.
Efficacy as measured by the MSQOL Scores
Time frame: Up to 5 weeks
Multiple Sclerosis Quality of Life (MSQOL) has a total score ranging from 0 to 100 with a higher score indicating a better quality of life.
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 0e2d2acf-2750-49d3-92af-2b34a90adfd0
- Retrieved
- 24/09/2026, 14:12:54
- SHA-256
- a9cba9e852c2246bbdc83cd9133691ef622007b95caa9929ba2d82e75fc4d9f7