Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03266965
• Date of registration: 04/07/2017
• Prospective Registration: Yes
• Primary sponsor: University of Miami
• Public title: Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
• Scientific title: Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
• Date of first enrolment: March 23, 2018
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03266965
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Kottil Rammohan, MD
• Affiliation: University of Miami

Key inclusion & exclusion criteria

Inclusion Criteria for Healthy Volunteers:

1. Male or female subjects between the ages of 18 and 60 will be eligible.

2. Subjects should be in good physical health without history of chronic illness and
should be generally considered healthy.

3. Spouses or caregivers of patients with MS would be encouraged to participate.

Inclusion Criteria for Patients with Multiple Sclerosis (MS):

1. Patients with MS regardless of the disease type, who experience severe fatigue will be
eligible to participate.

2. Fatigue Severity Score of >/= 4.0 will qualify as long as all other inclusion /
exclusion criteria are met.

3. Established MS by McDonald Criteria - 2010 Revision (24). Relapse Remitting (RR) and
progressive forms of MS are eligible

4. Severe fatigue that has lasted greater than 6 months

5. Clinically stable on a current therapy with any Disease Modifying Therapy (DMT)

Exclusion Criteria for Healthy Volunteers:

1. Adults unable to give informed consent due to cognitive impairment or mental
disorders.

2. Children below the age of consent

3. Pregnant women

4. Prisoners

5. History of chronic disorders like hypertension, diabetes, hyperlipidemia, depression,
hypothyroidism etc. that require chronic treatment

6. Known chronic fatigue syndrome

7. Blood disorders or coagulopathy

8. Chronic allergies or history of asthma.

9. Using antihistamines, bronchodilators or H2 blockers for hyperacidity

10. Using medications for sleep, or known sleep disorders

11. Any medication or condition deemed unsuitable by the PI

Exclusion Criteria for Patients with Multiple Sclerosis (MS):

1. Adults unable to give informed consent due to cognitive impairment or mental
disorders.

2. Children below the age of consent

3. Pregnant women

4. Prisoners

5. Systemic disorders known to cause fatigue such as severe anemia, infections, chronic
systemic infectious or inflammatory disorders, including known autoimmune disorders.

6. Chronic fatigue syndrome

7. Hypothyroidism

8. Systemic malignancy

9. Undergoing chemotherapy

10. Depression

11. Sleep disorders including narcolepsy, excessive day-time sleep.

12. History of substance abuse

13. Excessive consumption of coffee or over-the-counter stimulants

14. Concomitant medications of amantadine, methylphenidate, amphetamines, pemoline,
barbiturates, tizanidine, Monoamine oxidase inhibitor (MAO) inhibitors,
benzodiazepines, barbiturates, tricyclic antidepressants, antihistamines, H2 blockers
for gastro-esophageal reflux disease (GERD), selective serotonin reuptake inhibitors
(SSRIs) and any other medication that in the opinion of the PI should be excluded.

15. Patients who were using modafinil for treatment of fatigues prior to the study may
participate but will be required to undergo a washout of 2 weeks prior to entry into
the trial.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Dietary Supplement: L-Histidine

Drug: Carbidopa

Primary Outcome(s)

Number of adverse events experienced by participants. [Time Frame: 30 days]

Secondary Outcome(s)

Change of daytime sleepiness. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Change extent of fatigue. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Change of visual pain. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Change of fatigue impact scale. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Change in Quality of life. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Change of hunger sensitivity. [Time Frame: Screening(0 day), baseline(15 days) and final visit(30 days)]

Secondary ID(s)

W81XWH-16-1-0462

20161186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense