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NCT01416181 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 889
- Enrollment target
NCT01416181: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT01416181 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 889 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416181, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 889 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96): * Confirmed progression in EDSS (EDSS score increased from baseline \[BL\] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6); * Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk); * Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand). The EDSS measures disa
Interventions
- DRUG Placebo
- DRUG natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 889 participants |
| Start Date | 2011-09-13 |
| Est. Completion | 2016-04-13 |
| Phase | Phase 3 |
Why NCT01416181 stopped before completion
NCT01416181 is an interventional study that assigns participants to a tested intervention. The registered 889 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01416181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416181 about?
NCT01416181 is a clinical study titled "A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis". 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 treatm...
What is the current status of trial NCT01416181?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 889 participants. The study started on 2011-09-13. Estimated completion is 2016-04-13.
What interventions are being tested in trial NCT01416181?
The interventions under investigation include: Placebo (DRUG), natalizumab (DRUG).
Who is sponsoring clinical trial NCT01416181?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416181's enrollment target sits among peer trials
889 364th of 2000 higher than 1,637 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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