Your session is about to expire
← Back to Search
Monoclonal Antibodies
Natalizumab for Multiple Sclerosis (NAPPREMS Trial)
Phase 4
Waitlist Available
Led By Bianca Weinstock-Guttman, MD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
NAPPREMS Trial Summary
This trial will test if natalizumab, given monthly after delivery, can prevent postpartum relapses.
Eligible Conditions
- Multiple Sclerosis
NAPPREMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized Relapse Rate (ARR)
Secondary outcome measures
AUC-EDSS changes
Change in MRI
Confirmed (12 week) EDSS change
+3 moreOther outcome measures
Change in QOL measures
Side effects data
From 2011 Phase 4 trial • 19 Patients • NCT0114405270%
Infection
10%
gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Natalizumab
Interferon-beta-1b
NAPPREMS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: natalizumabExperimental Treatment1 Intervention
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
Group II: ControlActive Control1 Intervention
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved
Find a Location
Who is running the clinical trial?
State University of New York at BuffaloLead Sponsor
248 Previous Clinical Trials
49,511 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
3,266 Patients Enrolled for Multiple Sclerosis
Bianca Weinstock-Guttman, MD4.616 ReviewsPrincipal Investigator - SUNY Buffalo
State University of New York at Buffalo
3 Previous Clinical Trials
111 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
111 Patients Enrolled for Multiple Sclerosis
5Patient Review
I have been seeing her for over 16 years. She is very knowledgeable and compassionate. She always takes the time to listen to me and explain things in a way that I can understand. I really feel like she cares about me as a person.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: natalizumab
- Group 2: Control
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger