Histaminergic Basis of Fatigue in Multiple Sclerosis

NCT04764383 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 20201550
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Fatigue; Histamine

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Adverse events will be evaluated by treating physician.

  Up to 5 weeks

Secondary Outcomes (4)

• Efficacy as measured by FSS scores

  Up to 5 weeks

• Efficacy as measured by MFIS Scores

  Up to 5 weeks

• Efficacy as measured by the VAS scores

  Up to 5 weeks

• Efficacy as measured by the MSQOL Scores

  Up to 5 weeks

Study Arms (3)

PK/PD Group

EXPERIMENTAL

Participants in the Pharmacokinetic (PK)/pharmacodynamic (PD) Group will receive L-Histidine and Lodosyn daily for 7 consecutive days.

Drug: L-Histidine; Drug: Lodosyn

L-Histidine and Lodosyn followed by Placebo Group

PLACEBO COMPARATOR

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.

Drug: L-Histidine; Drug: Placebo; Drug: Lodosyn

Placebo followed by L-Histidine and Lodosyn Group

EXPERIMENTAL

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.

Drug: L-Histidine; Drug: Placebo; Drug: Lodosyn

Interventions

L-Histidine DRUG

1000 mg capsules taken by mouth (PO) twice daily (BID).

Also known as: Histamine

L-Histidine and Lodosyn followed by Placebo Group; PK/PD Group; Placebo followed by L-Histidine and Lodosyn Group

Placebo DRUG

Microcrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID).

L-Histidine and Lodosyn followed by Placebo Group; Placebo followed by L-Histidine and Lodosyn Group

Lodosyn DRUG

50 mg capsules taken PO BID.

L-Histidine and Lodosyn followed by Placebo Group; PK/PD Group; Placebo followed by L-Histidine and Lodosyn Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Histidine; Histamine; Carbidopa

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Methyldopa; Dihydroxyphenylalanine; Catecholamines; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kottil Rammohan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Neurology

Model Details: double-blind randomized cross-over

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)