MSFrontier

Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis
CompletedPhase 1Relapsing and progressiveNCT00559702

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Natalizumab

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

  • standard of care

What it measured

Main measures

  • Maximum observed concentration (Cmax) of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

    How the body handles the medicine

  • Time to maximum observed concentration (Tmax) of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

  • Area under the curve to the last measurable concentration (AUC0-last) of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

  • Apparent volume of distribution of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

  • Half-life of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

    How the body handles the medicine

  • Area under the curve extrapolated to infinity (AUC0-∞) of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

  • Apparent Clearance of natalizumab

    Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

    How the body handles the medicine

  • α4-integrin saturation

    Pre-dose, 4, 24 and 72 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56

    Immune response

Other measures (17)

  • Number of Participants with adverse events

    13-19 months

    Safety

  • Number of participants with abnormalities in vital signs

    13-19 months

    Safety

  • Number of participants with changes in the physical examination

    13-19 months

  • Number of participants with abnormal laboratory test results

    13-19 months

  • Number of participants with natalizumab antibodies

    Days 28, 42, 56, Weeks 24 and 32

  • Change from Baseline in expanded disability status scale (EDSS)

    Baseline, Weeks 8, 20, and 32

    Disability progression

  • Change form Baseline in Multiple Sclerosis Functional Composite Scale (MFSC)

    Baseline, Weeks 8, 20, and 32

    Disability progressionThinking and memoryWalking and mobilityArm and hand function

  • Change from Baseline in Symbol Digit Modalities Test (SDMT)

    Baseline, Weeks 8, 20, and 32

    Thinking and memory

  • Change from Baseline in visual analog scale (VAS)

    Baseline, Weeks 8, 20, and 32

    Quality of life (reported by participants)

  • Change from Baseline in visual function test

    Baseline, Weeks 8, 20, and 32

    Vision

Who could take part

Relapsing and progressive · 18 to 65

Key Inclusion Criteria: * For arms 1,2,3 and 4: Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS) * For arms 5 and 6: Diagnosis of relapsing forms of Multiple Sclerosis (MS). * No past history of receiving natalizumab. Key Exclusion Criteria: * For arms 1,2,3 and 4 Diagnosis of primary progressive MS or relapsing-remitting MS. * Form arms 5 and 6: Diagnosis of primary progressive MS or secondary progressive MS without the occurrence of relapses. NOTE: Other protocol defined inclusion/exclusion criteria may apply.

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 this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS.

Papers

Loading reviews and guidelines…

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History

    1. Started

      Oct 2007

    2. Main results due

      Nov 2011

    3. Finished

      Nov 2011

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