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NCT01047319 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,047
- Enrollment target
NCT01047319: Clinical Trial Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01047319 is a Phase 3 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,047 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047319, a Phase 3 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,047 participants
- Enrollment target
Study Summary
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
Primary Outcome
A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient h
Interventions
- DRUG Laquinimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,047 participants |
| Start Date | 2010-05-27 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 3 |
Why NCT01047319 stopped before completion
NCT01047319 is an interventional study that assigns participants to a tested intervention. Its 1,047 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 1 intervention - of which Laquinimod is the first listed.
NCT01047319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01047319 about?
NCT01047319 is a clinical study titled "A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis". To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
What is the current status of trial NCT01047319?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,047 participants. The study started on 2010-05-27. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT01047319?
The interventions under investigation include: Laquinimod (DRUG).
Who is sponsoring clinical trial NCT01047319?
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 NCT01047319's enrollment target sits among peer trials
1,047 283rd of 2000 higher than 1,718 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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