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Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

NCT01405820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2015-08-21

Study results available
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Summary

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

natalizumab IV

natalizumab for IV Infusion

DRUG

natalizumab SC

natalizumab for Subcutaneous Injection

DRUG

IV Placebo

Intravenous placebo to natalizumab

DRUG

SC Placebo

Subcutaneous placebo to natalizumab

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-04-30
Completion
2014-10-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405820 on ClinicalTrials.gov