Histaminergic Basis of Fatigue in Multiple Sclerosis
Phase 2
Withdrawn
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT04764383
- Lead Sponsor
- University of Miami
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo followed by L-Histidine and Lodosyn Group Placebo Participants in this group will receive Placebo daily for 2 consecutive weeks followed by L-Histidine and Lodosyn for an additional 2 consecutive weeks with a 1 week wash out period in between. L-Histidine and Lodosyn followed by Placebo Group Placebo Participants in this group will receive L-Histidine and Lodosyn daily for 2 consecutive weeks followed by Placebo for an additional 2 consecutive weeks with a 1-week wash-out period in between. PK/PD Group Lodosyn Participants in the Pharmacokinetic (PK)/pharmacodynamic (PD) Group will receive L-Histidine and Lodosyn daily for 7 consecutive days. L-Histidine and Lodosyn followed by Placebo Group Lodosyn Participants in this group will receive L-Histidine and Lodosyn daily for 2 consecutive weeks followed by Placebo for an additional 2 consecutive weeks with a 1-week wash-out period in between. L-Histidine and Lodosyn followed by Placebo Group L-Histidine Participants in this group will receive L-Histidine and Lodosyn daily for 2 consecutive weeks followed by Placebo for an additional 2 consecutive weeks with a 1-week wash-out period in between. Placebo followed by L-Histidine and Lodosyn Group Lodosyn Participants in this group will receive Placebo daily for 2 consecutive weeks followed by L-Histidine and Lodosyn for an additional 2 consecutive weeks with a 1 week wash out period in between. PK/PD Group L-Histidine Participants in the Pharmacokinetic (PK)/pharmacodynamic (PD) Group will receive L-Histidine and Lodosyn daily for 7 consecutive days. Placebo followed by L-Histidine and Lodosyn Group L-Histidine Participants in this group will receive Placebo daily for 2 consecutive weeks followed by L-Histidine and Lodosyn for an additional 2 consecutive weeks with a 1 week wash out period in between.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Up to 5 weeks Adverse events will be evaluated by treating physician.
- Secondary Outcome Measures
Name Time Method 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.
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 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.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States