Cetirizine vs Diphenhydramine for Multiple Sclerosis

JH
Overseen ByJeffrey Hernandez, DNP, APRN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Miami
Must be taking: Anti-CD20 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well individuals with multiple sclerosis (MS) tolerate two common allergy medicines, cetirizine and diphenhydramine, before receiving certain MS treatments. The researchers aim to determine which medicine is safer and more effective at preventing reactions during these treatments. Individuals with MS who are about to start or are currently receiving treatments like ocrelizumab, ublituximab, or rituximab may find this trial relevant. Participants will take either cetirizine or diphenhydramine before their regular treatment to assess its effectiveness. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research that could enhance the safety of MS treatments.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cetirizine and diphenhydramine are generally safe for use. Cetirizine does not increase the risk of reactions during infusions compared to diphenhydramine, making it a safe option for pre-treatment. Various studies have tested cetirizine, reporting few major issues. However, cetirizine might affect memory and concentration, which could concern individuals with multiple sclerosis (MS).

Diphenhydramine is often used to prevent allergic reactions during treatments and is known to reduce the risk of these reactions. However, it may cause more side effects, especially in children and older adults, such as drowsiness and confusion.

Both medications have been used safely, but each has its own possible side effects. Anyone considering joining a trial should discuss any concerns with their doctor.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using cetirizine and diphenhydramine for multiple sclerosis because these medications might offer a new approach to managing infusion-related reactions during anti-CD20 therapy. Unlike traditional treatments that focus directly on modifying the immune system, cetirizine and diphenhydramine are antihistamines that work by blocking histamine action, potentially reducing allergic reactions and improving patient comfort during infusions. This could make the infusion process smoother and more tolerable, providing an added layer of care for patients undergoing standard multiple sclerosis treatments.

What evidence suggests that cetirizine and diphenhydramine could be effective pre-medications for multiple sclerosis patients receiving anti-CD20 infusion therapy?

This trial will compare Cetirizine and Diphenhydramine as pre-medications for anti-CD20 infusion therapy in multiple sclerosis (MS) patients. Research has shown that cetirizine does not increase the risk of reactions during infusions compared to diphenhydramine, suggesting it is a safe choice. Participants in the Cetirizine Group will receive cetirizine, which causes fewer drowsiness issues in MS patients taking ocrelizumab, another anti-CD20 drug. However, cetirizine alone has not been very effective in managing flu-like symptoms related to MS. Participants in the Diphenhydramine Group will receive diphenhydramine, often used to prevent allergic reactions during infusions, but it can cause drowsiness. These findings help clarify how each medication might work as a pre-treatment for MS patients.16789

Who Is on the Research Team?

JH

Jeffrey Hernandez, DNP, APRN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults with multiple sclerosis who are starting or already receiving anti-CD20 treatments (ocrelizumab, ublituximab, or rituximab). Participants must be able to read and speak English or Spanish and give informed consent.

Inclusion Criteria

I am 18 years old or older.
I can read and speak English or Spanish.
* Able to and willing to give informed consent
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of cetirizine or diphenhydramine as a pre-medication before anti-CD20 infusion therapy

6 hours per visit
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 24-hour follow-up calls

24 hours post-infusion
Follow-up calls

Long-term monitoring

Participants are monitored for treatment-related adverse events and serious adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Cetirizine
  • Diphenhydramine

Trial Overview

The study compares two allergy medicines—cetirizine and diphenhydramine—as pre-medications to see which helps MS patients better tolerate their anti-CD20 infusion therapy. It looks at both comfort and safety during treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cetirizine GroupExperimental Treatment1 Intervention
Group II: Diphenhydramine GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38674305/

Comparing the Risk of Infusion-Related Reactions and ...

Overall, our results suggest that cetirizine does not increase the risk of infusion-related reactions compared to diphenhydramine.

MS-related Flu-Like Syndrome Fails to Respond ...

Read about a clinical trial showing that the over-the-counter allergy medicine cetirizine failed to alleviate a flu-like condition in MS ...

Diabetes drug and antihistamine could together repair ...

Diabetes drug and antihistamine could together repair multiple sclerosis damage, trial finds. Dr Nick Cunniffe running a 'visual evoked ...

Comparing the Risk of Infusion-Related Reactions and ...

Conclusions: Overall, our results suggest that cetirizine does not increase the risk of infusion-related reactions compared to diphenhydramine.

Multiple sclerosis-related optic neuropathy can be reversed ...

Patients on the antihistamines showed slight improvement in terms of delays in the time it took for visual information to travel from the eye to the brain.

Management of flu-like syndrome with cetirizine in patients ...

Safety and tolerability of cetirizine ... Can we predict flu-like symptoms in patients with multiple sclerosis treated with interferon beta?

8 Drugs To Avoid While on Multiple Sclerosis Treatment

Some antihistamines may cause poor memory and concentration, making it harder for people with MS to manage their cognitive symptoms. 8.

Management of flu-like syndrome with cetirizine in patients ...

The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from ...

ZYRTEC® - (cetirizine hydrochloride) Tablets and Syrup For ...

On a mg/kg basis, most of the 168 patients received between 0.2 and 0.4 mg/kg of cetirizine HCl. The safety of cetirizine in 399 patients aged 12 to 24 months ...