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NCT00559702 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT00559702 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 76 participants.
The verdict
NCT00559702, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study 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.
Interventions
- OTHER standard of care
- DRUG natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00559702
The ClinicalTrials.gov registry entry for NCT00559702 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which standard of care is the first listed.
NCT00559702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00559702 about?
NCT00559702 is a clinical study titled "Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)". 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 objectiv...
What is the current status of trial NCT00559702?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2007-10. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00559702?
The interventions under investigation include: standard of care (OTHER), natalizumab (DRUG).
Who is sponsoring clinical trial NCT00559702?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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