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NCT01244139 · ClinicalTrials.gov registry record · Phase 1
Safety Study of BIIB033 in Subjects With Multiple Sclerosis
A Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT01244139 is a Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 47 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01244139, a Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIIB033
Study Locations (1)
Colorado
- Research Site - Centennial
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01244139
The ClinicalTrials.gov registry entry for NCT01244139 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01244139 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT01244139 about?
NCT01244139 is a clinical study titled "Safety Study of BIIB033 in Subjects With Multiple Sclerosis". The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects pe...
What is the current status of trial NCT01244139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2010-10. Estimated completion is 2012-04.
What conditions does trial NCT01244139 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT01244139?
The interventions under investigation include: Placebo (DRUG), BIIB033 (DRUG).
Who is sponsoring clinical trial NCT01244139?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01244139 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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