Multiple Sclerosis
Conditions
Keywords
Fatigue, Histamine
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).
Interventions
DRUGL-Histidine
1000 mg capsules taken by mouth (PO) twice daily (BID).
DRUGPlacebo
Microcrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID).
DRUGLodosyn
50 mg capsules taken PO BID.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
double-blind randomized cross-over
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Up to 5 weeks | Adverse events will be evaluated by treating physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as measured by FSS scores | 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 | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed