Trials / Completed
CompletedNCT01884935
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Natalizumab | As specified in the treatment arm |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2013-06-24
- Last updated
- 2016-06-23
Locations
5 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT01884935. Inclusion in this directory is not an endorsement.