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NCT00509145 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

A Phase 3 study of Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
1,106
Enrollment target
20
Study locations

NCT00509145: Completed Phase 3 study of Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT00509145 is a Phase 3 study of Multiple Sclerosis that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,106 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00509145, a Phase 3 study of Multiple Sclerosis, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
1,106 participants
Enrollment target
20
Study locations

Study Summary

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

Primary Outcome

A relapse was defined as the appearance of at least one new neurological abnormality or the reappearance of at least one previously observed neurological abnormalities lasting greater than or equal to 48 hours and immediately preceded by an improving neurological state of greater than or equal to 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with one or more of

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Laquinimod

Study Locations (20)

Colorado

  • Teva Investigational Site 1090 - Centennial
  • Teva Investigational Site 1088 - Fort Collins

New York

  • Teva Investigational Site 1082 - New York
  • Teva Investigational Site 1079 - Rochester

Pennsylvania

  • Teva Investigational Site 1100 - Hershey
  • Teva Investigational Site 1087 - Philadelphia

Arizona

  • Teva Investigational Site 1076 - Phoenix

Connecticut

  • Teva Investigational Site 1094 - New Haven

Illinois

  • Teva Investigational Site 1102 - Northbrook

Indiana

  • Teva Investigational Site 1081 - Fort Wayne

Iowa

  • Teva Investigational Site 1083 - Des Moines

Trial Details

FieldValue
Enrollment Target 1,106 participants
Start Date 2007-11-13
Est. Completion 2010-11-08
Phase Phase 3

What the finished NCT00509145 record still lists

NCT00509145 is an interventional study that assigns participants to a tested intervention. Its 1,106 participants enrollment target places it among the larger protocols in the corpus, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (90% higher).

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00509145 names 20 study sites across 17 states, led by Colorado, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00509145 about?

NCT00509145 is a clinical study titled "Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)". Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

What is the current status of trial NCT00509145?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,106 participants. The study started on 2007-11-13. Estimated completion is 2010-11-08.

What conditions does trial NCT00509145 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT00509145?

The interventions under investigation include: Placebo (OTHER), Laquinimod (DRUG).

Who is sponsoring clinical trial NCT00509145?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00509145 being conducted?

This trial has 20 study locations across Arizona, Colorado, Connecticut, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00509145's enrollment target sits among peer trials

1,106 24th of 315 higher than 292 of 315 other Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis 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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Source: ClinicalTrials.gov NCT00509145, the US trial registry maintained by the National Library of Medicine. NCT00509145 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.