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Antihistamine Premedication for Multiple Sclerosis (PRECEPT Trial)

Phase 3
Waitlist Available
Led By Kyle Smoot, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patient with relapsing or progressive forms of MS, age 18 to 70 inclusive at the time of consent
Naïve to OCR and will receive OCR as part of standard of care for MS treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during or after receiving the first full 600mg dose infusion on day 168.
Awards & highlights

PRECEPT Trial Summary

This trial will compare the side effects of two different antihistamines in people receiving a MS drug.

Who is the study for?
This trial is for adults aged 18-70 with relapsing or progressive forms of multiple sclerosis who haven't been treated with ocrelizumab. They must understand the study and be able to consent, have an EDSS score ≤6.5, and women must use effective contraception. Excluded are those with certain mental conditions, active infections like hepatitis B/C or tuberculosis, history of PML or HIV positive status, severe diseases including depression within the last year, current use of specific immune medications, or allergies to antihistamines used in the study.Check my eligibility
What is being tested?
The study tests if cetirizine causes fewer side effects than diphenhydramine when premedicating patients before their infusion treatment (ocrelizumab) for multiple sclerosis without increasing infusion-related reactions. It's a randomized controlled pilot trial lasting six months where participants receive one of these antihistamines as part of their standard care.See study design
What are the potential side effects?
Possible side effects include typical reactions to antihistamines such as drowsiness, dry mouth, dizziness and potential increased risk of infusion-related reactions like fever, rash or difficulty breathing during ocrelizumab treatment.

PRECEPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old with relapsing or progressive MS.
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I have not been treated with OCR but will start it for my MS.
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I can walk with some assistance or devices.
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I understand the study's risks and can sign the consent form.
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I am using effective birth control and will continue during the study.

PRECEPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during or after receiving the first full 600mg dose infusion on day 168.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during or after receiving the first full 600mg dose infusion on day 168. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
Secondary outcome measures
Modified Fatigue Impact Scale (MFIS) Score on Day 168
Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168
Proportion of Participants With Infusion-related Reaction (IRR) on Day 14
+4 more

Side effects data

From 2014 Phase 4 trial • 208 Patients • NCT01825941
16%
Drowsy
8%
Restlessness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metoclopramide + Diphenhydramine
Metoclopramide + Placebo

PRECEPT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: diphenhydramineExperimental Treatment1 Intervention
25 mg diphenhydramine capsule, generic, sourced from Major Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
Group II: cetirizineActive Control1 Intervention
10 mg cetirizine tablet, generic, sourced from Mylan Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
diphenhydramine
2011
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,504 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
191 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,661 Total Patients Enrolled
26 Trials studying Multiple Sclerosis
4,729 Patients Enrolled for Multiple Sclerosis
Kyle Smoot, MDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
64 Patients Enrolled for Multiple Sclerosis

Media Library

diphenhydramine Clinical Trial Eligibility Overview. Trial Name: NCT04175834 — Phase 3
Multiple Sclerosis Research Study Groups: diphenhydramine, cetirizine
Multiple Sclerosis Clinical Trial 2023: diphenhydramine Highlights & Side Effects. Trial Name: NCT04175834 — Phase 3
diphenhydramine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175834 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any serious dangers associated with taking cetirizine?

"There is a fair amount of data to support the safety of cetirizine as it has completed Phase 3 clinical trials."

Answered by AI

Are there any unfilled vacancies for participants in this clinical trial?

"Unfortunately, this particular trial is not enrolling patients at the moment. Although the study was last updated on January 10th, 2022, it is no longer seeking candidates. There are however, other 408 trials that might be of interest and are currently looking for participants."

Answered by AI

For what do most doctors recommend cetirizine?

"Cetirizine is commonly used to mitigate the symptoms of respiratory allergies, though it can also be effective for treating grass allergies, seasonal allergic rhinitis, and chronic idiopathic urticaria."

Answered by AI

Is this research being conducted for the first time?

"Research on cetirizine began in 2020 with a trial sponsored by Genentech, Inc. This original study had 52 participants and after its success, the drug received Phase 3 approval. There are currently 4 ongoing trials involving cetirizine across 9 cities and 6 countries."

Answered by AI

How can I sign up to take part in this experiment?

"This trial is investigating whether 52 patients with multiple sclerosis, aged 18 to 70, will respond well to the study medication. To be eligible for the study, potential participants must meet certain conditions, which are as follows: their Estimated Expanded Disability Status Scale (EDSS) must be ≤ 6.5 at screening; female patients of childbearing potential must practice effective contraception and continue contraception during the study; in the opinion of the investigators, they should have no significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study; male or female patient with relapsing or progressive forms of MS, age 18 to 70 inclusive at the"

Answered by AI

Does this study require participants to be of a certain age?

"The target patient population for this research is adults aged 18 to 70 years old."

Answered by AI

Is cetirizine a common medication used in research?

"There are 4 cetirizine clinical trials underway, 1 of which is in the final stage. The majority of these research studies are being conducted in Bloomington, Indiana; however, there are a total of 21 locations running these investigations."

Answered by AI

How many patients are being monitored in this clinical trial?

"This study is not actively recruiting patients at the moment. The listing for this trial was first posted on February 5th, 2020 and updated January 10th, 2022. There are presently 404 trials actively looking for patients with multiple sclerosis and 4 trials for cetirizine that need participants."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025