A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis

ClinicalTrials.gov ID: NCT01416181

Public ClinicalTrials.gov record NCT01416181. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 12:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2). Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores. Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS. The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

Study identification

NCT ID: NCT01416181
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Biogen; Industry
Enrollment: 889 participants

Conditions and interventions

Conditions

Secondary Progressive Multiple Sclerosis

Interventions

natalizumab Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 58 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 12, 2011
Primary completion: Jul 27, 2015
Completion: Apr 12, 2016
Last update posted: Sep 10, 2017

2011 – 2016

United States locations

U.S. sites: 35
U.S. states: 22
U.S. cities: 32

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85013	—
Research Site	Tucson	Arizona	85741	—
Research Site	Fullerton	California	92835	—
Research Site	Los Angeles	California	90027	—
Research Site	Aurora	Colorado	80045	—
Research Site	Tampa	Florida	33612	—
Research Site	Chicago	Illinois	60637	—
Research Site	Lake Barrington	Illinois	60010	—
Research Site	Peoria	Illinois	61606	—
Research Site	Indianapolis	Indiana	46202	—
Research Site	Indianapolis	Indiana	46256	—
Research Site	Kansas City	Kansas	66160	—
Research Site	Lexington	Kentucky	40513	—
Research Site	Lexington	Kentucky	40536	—
Research Site	Baltimore	Maryland	21287	—
Research Site	Burlington	Massachusetts	01805	—
Research Site	Omaha	Nebraska	68198	—
Research Site	Lebanon	New Hampshire	03756	—
Research Site	Teaneck	New Jersey	07666	—
Research Site	Latham	New York	12110	—
Research Site	New York	New York	10029	—
Research Site	Advance	North Carolina	27006	—
Research Site	Charlotte	North Carolina	28207	—
Research Site	Raleigh	North Carolina	27607	—
Research Site	Akron	Ohio	44320	—
Research Site	Uniontown	Ohio	44685	—
Research Site	Oklahoma City	Oklahoma	73104	—
Research Site	Clackamas	Oregon	97015	—
Research Site	Portland	Oregon	97225	—
Research Site	Portland	Oregon	97239	—
Research Site	Nashville	Tennessee	37215	—
Research Site	Charlottesville	Virginia	22903	—
Research Site	Seattle	Washington	98101	—
Research Site	Green Bay	Wisconsin	54311	—
Research Site	Milwaukee	Wisconsin	53215	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 126 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01416181, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 10, 2017 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01416181 live on ClinicalTrials.gov.

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