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NCT02284568 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 374
- Enrollment target
NCT02284568: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02284568 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 374 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (181% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02284568, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 374 participants
- Enrollment target
Study Summary
This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.
Primary Outcome
Brain atrophy (BA) was measured using magnetic resonance imaging (MRI) scans of the brain. BA was analyzed using baseline-adjusted repeated measures analysis of covariance (ANCOVA- SAS® PROC MIXED) in which 1 contrast was constructed in order to compare between laquinimod 0.6 mg and placebo. The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volum
Interventions
- DRUG Placebo
- DRUG Laquinimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2015-01-12 |
| Est. Completion | 2017-10-01 |
| Phase | Phase 2 |
What the finished NCT02284568 record still lists
NCT02284568 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (181% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02284568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02284568 about?
NCT02284568 is a clinical study titled "A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo". This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.
What is the current status of trial NCT02284568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 374 participants. The study started on 2015-01-12. Estimated completion is 2017-10-01.
What interventions are being tested in trial NCT02284568?
The interventions under investigation include: Placebo (DRUG), Laquinimod (DRUG).
Who is sponsoring clinical trial NCT02284568?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02284568's enrollment target sits among peer trials
374 118th of 2000 higher than 1,883 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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