Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Interventions

  • DRUG Placebo
  • DRUG BIIB033

Study Locations (1)

Colorado

  • Research Site - Centennial

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2010-10
Est. Completion 2012-04
Phase Phase 1

Sponsor

Biogen

334 total trials

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.

Similar trials for Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.