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NCT01707992 · ClinicalTrials.gov registry record · Phase 3
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,199
- Enrollment target
NCT01707992: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01707992 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 2,199 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01707992, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,199 participants
- Enrollment target
Study Summary
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).
Primary Outcome
Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). Data is presented as distribution of CDP (number of participants w
Interventions
- DRUG Placebo
- DRUG Laquinimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,199 participants |
| Start Date | 2013-02-20 |
| Est. Completion | 2017-07-04 |
| Phase | Phase 3 |
What the finished NCT01707992 record still lists
NCT01707992 is an interventional study that assigns participants to a tested intervention. Its 2,199 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 (185% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01707992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01707992 about?
NCT01707992 is a clinical study titled "The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)". This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the...
What is the current status of trial NCT01707992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,199 participants. The study started on 2013-02-20. Estimated completion is 2017-07-04.
What interventions are being tested in trial NCT01707992?
The interventions under investigation include: Placebo (DRUG), Laquinimod (DRUG).
Who is sponsoring clinical trial NCT01707992?
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 NCT01707992's enrollment target sits among peer trials
2,199 95th of 2000 higher than 1,906 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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