Multiple SclerosisPhase 2NCT04764383
Histaminergic Basis of Fatigue in Multiple Sclerosis
A Phase 2 study testing L-Histidine and Lodosyn in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- L-Histidine and Lodosyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 30 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- L-Histidine, Placebo, Lodosyn
- Keywords
- Fatigue, Histamine
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-HistidineDrug
Also called Histamine
1000 mg capsules taken by mouth (PO) twice daily (BID).
PlaceboDrug
Microcrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID).
LodosynDrug
50 mg capsules taken PO BID.
| Study group | Role | What they receive |
|---|---|---|
| PK/PD Group | Experimental | Participants in the Pharmacokinetic (PK)/pharmacodynamic (PD) Group will receive L-Histidine and Lodosyn daily for 7 consecutive days. Receives: 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. Receives: 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. Receives: Drug: L-Histidine; Drug: Placebo; Drug: Lodosyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Adverse events will be evaluated by treating physician.
Measured: Up to 5 weeks
Secondary outcomes (4)
Efficacy as measured by FSS scores
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.
Measured: Up to 5 weeks
Efficacy as measured by MFIS Scores
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.
Measured: Up to 5 weeks
Efficacy as measured by the VAS scores
The Visual Analog Scale (VAS) allows participants to rate their health on a 20 cm vertical with a higher number indicating better outcomes.
Measured: Up to 5 weeks
Efficacy as measured by the MSQOL Scores
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.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Why it stopped: Withdrawn as more data drug analysis is recommended before the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind randomized cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kottil W. Rammohan, University of Miami
- Investigators
- Kottil Rammohan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764383
- Sponsor's protocol ID
- 20201550
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histaminergic Basis of Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04764383
- Acronym / sponsor ID
- 20201550
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, Histamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn as more data drug analysis is recommended before the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- double-blind randomized cross-over
| Arm | Type | Receives |
|---|---|---|
| PK/PD Group | Experimental | Drug: L-Histidine, Drug: LodosynParticipants 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 | Placebo comparator | Drug: L-Histidine, Drug: Placebo, Drug: LodosynParticipants 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 | Experimental | Drug: L-Histidine, Drug: Placebo, Drug: LodosynParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-HistidineAlso: Histamine1000 mg capsules taken by mouth (PO) twice daily (BID). | Drug | L-Histidine and Lodosyn followed by Placebo Group, PK/PD Group, Placebo followed by L-Histidine and Lodosyn Group |
| PlaceboMicrocrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID). | Drug | L-Histidine and Lodosyn followed by Placebo Group, Placebo followed by L-Histidine and Lodosyn Group |
| Lodosyn50 mg capsules taken PO BID. | Drug | L-Histidine and Lodosyn followed by Placebo Group, PK/PD Group, Placebo followed by L-Histidine and Lodosyn Group |
Primary outcome
Incidence of Adverse Events
Time frame: Up to 5 weeks
Adverse events will be evaluated by treating physician.
4 secondary outcomes
Efficacy as measured by FSS scores
Time frame: Up to 5 weeks
Efficacy as measured by MFIS Scores
Time frame: Up to 5 weeks
Efficacy as measured by the VAS scores
Time frame: Up to 5 weeks
Efficacy as measured by the MSQOL Scores
Time frame: Up to 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kottil Rammohan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-Histidine and Lodosyn in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.