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Antihistamine Premedication for Multiple Sclerosis (PRECEPT Trial)
PRECEPT Trial Summary
This trial will compare the side effects of two different antihistamines in people receiving a MS drug.
PRECEPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRECEPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 208 Patients • NCT01825941PRECEPT Trial Design
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Who is running the clinical trial?
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- I am between 18 and 70 years old with relapsing or progressive MS.I can walk with some assistance or devices.I have untreated hepatitis C or tuberculosis, no history of PML, and I am not HIV positive.I haven't had severe depression or uncontrolled illness in the past year.I have not been treated with OCR but will start it for my MS.I currently have a severe or ongoing infection.I understand the details and risks of the study.I understand the study's risks and can sign the consent form.I am currently taking medication that affects my immune system.You have a current hepatitis B infection.I am using effective birth control and will continue during the study.
- Group 1: diphenhydramine
- Group 2: cetirizine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
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."
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