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Natalizumab for Multiple Sclerosis (NAPPREMS Trial)
NAPPREMS Trial Summary
This trial will test if natalizumab, given monthly after delivery, can prevent postpartum relapses.
- Multiple Sclerosis
NAPPREMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNAPPREMS 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 2011 Phase 4 trial • 19 Patients • NCT01144052NAPPREMS Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with primary progressive multiple sclerosis.You are receiving Tysabri treatment and are also using IVIG.You have had a bad reaction to natalizumab in the past, or your body has made antibodies against it.You have had a relapse or started taking disease-modifying treatments during pregnancy.Women who have given birth within the last month.You have been diagnosed with a type of MS that comes and goes (relapses).
- Group 1: natalizumab
- Group 2: Control
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
How many volunteers have been recruited for this research endeavor?
"Unfortunately, recruitment for this trial has ceased since its last edit on August 23rd 2022. However, should you be interested in other research opportunities related to multiple sclerosis, there are currently 549 studies and 7 trials recruiting patients."
What potential dangers might be associated with this therapeutic treatment?
"The safety of this particular medicine has been established, as it is beneficial in Phase 4 trials. Therefore, our team at Power gave the treatment a score of 3."
Are there any vacancies in this clinical research for potential participants?
"At present, this medical trial is not enrolling new patients. Initially posted on August 1st 2015 and last updated in the 23rd of August 2022, those looking to participate in a clinical study should look into other trials for multiple sclerosis as there are presently 549 actively recruiting participants along with 7 studies that offer this treatment option."
What conditions is this treatment regimen typically used to address?
"This treatment may be beneficial for those who are intolerant to conventional therapy, those looking for a standalone solution, and patients with Crohn's disease."
Is this particular treatment supported by other past clinical investigations?
"Currently, there are seven clinical trials being conducted to assess this treatment. Two of those investigations have reached Phase 3 in their research cycle and the remaining five are based out of Fort Collins, Colorado, with 173 other sites running similar studies."
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