Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01884935

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:
A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

Clinical Trial Summary

The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01884935
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 1
Start date July 2013
Completion date September 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT02549703 - Mitochondrial Dysfunction and Disease Progression
Completed NCT02293967 - Mass Balance Study of MT-1303 Phase 1
Terminated NCT02222948 - Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis Phase 2
Terminated NCT01790269 - Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Terminated NCT01701856 - Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis Phase 4
Completed NCT00525668 - Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) Phase 1/Phase 2
Terminated NCT00398528 - An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis Phase 4
Completed NCT00315367 - A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties Phase 4
Terminated NCT04032171 - Study of Evobrutinib in Participants With RMS Phase 3
Completed NCT01930708 - A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes Phase 4
Completed NCT03000647 - Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis N/A
Completed NCT02205489 - Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA Phase 4
Completed NCT02753088 - Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis Phase 3
Recruiting NCT01466114 - Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition Phase 2
Completed NCT01416155 - Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis Phase 2
Completed NCT01244139 - Safety Study of BIIB033 in Subjects With Multiple Sclerosis Phase 1
Completed NCT00559702 - Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Phase 1
Completed NCT00493116 - Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta Phase 4
Terminated NCT01706107 - Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Completed NCT01943526 - Ireland Natalizumab (TYSABRI) Observational Program