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)

CompletedPhase 1Relapsing MSNCT018849352012-005082-13

What it found

No results found

We found no results in the registry or in papers.

This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Natalizumab

    Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

What it measured

Main measures

  • predose (trough) concentrations from multiple dosing (Cpredose)

    Up to week 16

    How the body handles the medicine

  • maximum plasma concentration (Cmax)

    Up to Week 16

    How the body handles the medicine

  • time to maximum plasma concentration (Tmax)

    Up to Week 16

    How the body handles the medicine

  • area under the plasma concentration curve from time of first dose to infinity (AUCinf)

    Up to Week 16

    How the body handles the medicine

  • apparent clearance (Cl/F)

    Up to Week 16

    How the body handles the medicine

  • volume of distribution

    Up to Week 16

  • elimination half-life (t1/2)

    Up to Week 16

    MRI lesionsHow the body handles the medicine

  • The primary endpoints are as follows: maximum plasma concentration (Cmax) for the 24-hour sampling period, predose (trough) concentrations (Cpredose) from multiple dosing time to maximum plasma concentration (Tmax) for the 24-hour sampling period area under the plasma concentration curve from time of first dose to infinity (AUCinf), apparent clearance (Cl/F), volume of distribution, elimination h

    MRI lesionsHow the body handles the medicine

Other measures (4)

  • the average and minimum saturation values of α4 integrin over the dosing interval

    Up to Week 16

  • incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs

    Up to Week 16

    Safety

  • the presence of anti-natalizumab antibodies

    Up to Week 16

  • The secondary endpoints are as follows: the average and minimum saturation values of α4 integrin over the dosing interval, incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs, the presence of anti-natalizumab antibodies

    Safety

Who could take part

Relapsing MS · 10 to 17

Show the full criteria

Inclusion criteria

Key Inclusion Criteria: - Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI) Key Exclusion Criteria: * History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator. * Prior natalizumab therapy. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        Jul 2013

      2. Main results due

        Sept 2014

      3. Finished

        Sept 2014

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