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NCT01625182 · ClinicalTrials.gov registry record · Phase 3
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT01625182: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01625182 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625182, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study Summary
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
Primary Outcome
Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the s
Interventions
- DRUG Placebo Comparator
- DRUG Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2012-12-22 |
| Est. Completion | 2016-09-03 |
| Phase | Phase 3 |
What the finished NCT01625182 record still lists
NCT01625182 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01625182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625182 about?
NCT01625182 is a clinical study titled "Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.". The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
What is the current status of trial NCT01625182?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2012-12-22. Estimated completion is 2016-09-03.
What interventions are being tested in trial NCT01625182?
The interventions under investigation include: Placebo Comparator (DRUG), Fingolimod (DRUG).
Who is sponsoring clinical trial NCT01625182?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625182's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 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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