Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00559702

Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing-Remitting Multiple Sclerosis
  • Sclerosis
  • Secondary Progressive Multiple Sclerosis
Clinical Trial Details
NCT number NCT00559702
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 1
Start date October 2007
Completion date November 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT02549703 - Mitochondrial Dysfunction and Disease Progression
Terminated NCT02222948 - Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis Phase 2
Completed NCT02293967 - Mass Balance Study of MT-1303 Phase 1
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 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
Completed NCT02310048 - Comparative Oral Bioavailability Study of MT-1303 Phase 1