Trial · NCT00509145

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

NCT00509145, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2021-11-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS). Trials, record NCT00509145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00509145

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)
NCT number: NCT00509145
Status: Completed
Phases: Phase 3
Enrollment: 1,106 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Multiple Sclerosis
Interventions: Laquinimod, Placebo
First posted: 2007-07-31
Last updated: 2021-11-02
Other registries' IDs: eudract:2007-003226-19
Results first posted: 2021-11-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period	Up to Month 24	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 the following: An increase of greater than or equal to 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation, an increase of one grade in the actual score of greater than or equal to 2 of the 7 functional systems (FS), as compared to previous evaluation, or an increase of 2 grades in the actual score of one FS as compared to the previous evaluation.
Secondary	Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images	Month 12, Month 24	Composite score was calculated as the sum of the number of gadolinium (Gd)-enhanced lesions at Month 12 and the number of gadolinium (Gd)-enhanced lesions at Month 24 on T1-Weighted MRI scans.
Secondary	Composite Endpoint: Sum of the Number of New/Enlarging T2 Lesions	Month 12, Month 24	Composite score calculated as the sum of T2 lesions at Months 12 and 24 that are new or enlarged.
Secondary	Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Baseline to Month 24	EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). A confirmed progression of EDSS is defined as at least 1 point increase from baseline if baseline EDSS was between 0 and 5.0, or at least 0.5 point increase if baseline EDSS was 5.5 or higher, confirmed 3 months later. Participants were assessed between baseline and month 24 visit. Participants that met these criteria for any 3 consecutive months were counted in the progression category. Progression could not be confirmed during an MS relapse. Data is presented as a distribution of confirmed disease progression (CDP) events (number of participants with CDP).
Secondary	Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	Baseline, Month 24	The Multiple Sclerosis Functional Composite is an instrument assessing disability that consists of 3 clinical assessments. The 3 are Timed 25-Foot Walk, 9-Hole Peg Test which measures upper extremity (arm and hand) function, and PASAT (Paced Auditory Serial Addition Test) which is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. A Z-score is used to define a common metric from the 3 assessments that constitute the MSFC score. The study's population at baseline was used as reference population for the Z-score calculation. A Z-score of 0 represents the population mean at baseline. Higher Z-scores correspond to an improved outcome.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period	Up to Month 24	Intent to treat (ITT) analysis set included all randomized participants.	Confirmed relapses	MEAN
SECONDARY	Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images	Month 12, Month 24	ITT analysis set included all randomized participants. Number of participants analyzed included the number of participants evaluable at each time point.	Lesions	MEAN
SECONDARY	Composite Endpoint: Sum of the Number of New/Enlarging T2 Lesions	Month 12, Month 24	ITT analysis set included all randomized participants. Number of participants analyzed included the number of participants evaluable at each time point.	Lesions	MEAN
SECONDARY	Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Baseline to Month 24	ITT analysis set included all randomized participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	Baseline, Month 24	ITT analysis set included all randomized participants. Number of participants analyzed included the number of participants evaluable at each time point.	Z score	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period	Laquinimod		0.54	Standard Deviation 0.88	Confirmed relapses
Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period	Placebo		0.67	Standard Deviation 0.92	Confirmed relapses
Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images	Laquinimod		1.86	Standard Deviation 5.02	Lesions
Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images	Placebo		2.92	Standard Deviation 7.58	Lesions
Composite Endpoint: Sum of the Number of New/Enlarging T2 Lesions	Laquinimod		5.26	Standard Deviation 9.08	Lesions
Composite Endpoint: Sum of the Number of New/Enlarging T2 Lesions	Placebo		7.87	Standard Deviation 12.56	Lesions
Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Laquinimod	Progressed	54		Participants
Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Placebo	Progressed	78		Participants
Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Laquinimod	Progression Free	496		Participants
Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)	Placebo	Progression Free	478		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Laquinimod	550
Overall Study	STARTED	Placebo	556
Overall Study	COMPLETED	Laquinimod	437
Overall Study	COMPLETED	Placebo	427
Overall Study	NOT COMPLETED	Laquinimod	113
Overall Study	NOT COMPLETED	Placebo	129

Source ClinicalTrials.gov

Adverse events354

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain upper	Gastrointestinal disorders	Laquinimod 0.6 mg	28	550	33
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	29	556	34
other	Diarrhoea	Gastrointestinal disorders	Laquinimod 0.6 mg	42	550	49
other	Diarrhoea	Gastrointestinal disorders	Placebo	33	556	41
other	Nausea	Gastrointestinal disorders	Laquinimod 0.6 mg	34	550	38
other	Nausea	Gastrointestinal disorders	Placebo	32	556	38
other	Fatigue	General disorders	Laquinimod 0.6 mg	25	550	28
other	Fatigue	General disorders	Placebo	29	556	36
other	Influenza	Infections and infestations	Laquinimod 0.6 mg	33	550	39
other	Influenza	Infections and infestations	Placebo	44	556	50

1 to 10 of 354Source ClinicalTrials.gov

See all 354 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Laquinimod 0.6 mg	0	550
Total, all-cause mortality	Placebo	3	556
Total, other adverse events	Laquinimod 0.6 mg	368	550
Total, other adverse events	Placebo	346	556
Total, serious adverse events	Laquinimod 0.6 mg	61	550
Total, serious adverse events	Placebo	53	556

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22417253	DERIVED	PubMed
24029546	DERIVED	PubMed
26000222	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Laquinimod 0.6 mg vs Placebo: deaths from any cause	Trial comparisons
Laquinimod 0.6 mg vs Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Paced Visual Serial Addition Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00509145

GET https://conductscience.org/api/trials/v1/NCT00509145/events?page=2

API reference For AI assistants