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PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

NCT01884935 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-06-23

No results posted yet for this study

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.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

BIOLOGICAL

Natalizumab

As specified in the treatment arm

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884935 on ClinicalTrials.gov