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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 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 889 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01416181
The ClinicalTrials.gov registry entry for NCT01416181 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 889 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01416181 reports 0 study locations.
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.
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