Trial · NCT00605215

BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)

NCT00605215, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2022-04-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®). Trials, record NCT00605215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605215

On this page

Trial

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

Title: BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)
NCT number: NCT00605215
Status: Completed
Phases: Phase 3
Enrollment: 1,331 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Multiple Sclerosis
Interventions: Laquinimod, Placebo, Avonex®
First posted: 2008-01-30
Last updated: 2022-04-21
Other registries' IDs: eudract:2007-005450-23
Results first posted: 2022-04-21

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Annualized Rate of Confirmed Relapses	Baseline up to Month 24	A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale \[EDSS\] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems \[FS\], or an increase of 2 grades in the score of 1 FS as compared to the previous evaluation). Total number of confirmed relapses during the treatment period was divided by the sum of number of days on study in the treatment period and then multiplied by the number of days in the year to calculate the annualized relapse rate. Annualized relapse rate was derived from a baseline-adjusted negative binomial regression.
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.
Secondary	Percent Change From Baseline in Brain Volume	Baseline, Month 24	Change in brain volume was derived from MRI scans obtained at baseline and at Month 24.
Secondary	Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS	Baseline up to Month 24	A confirmed progression of EDSS was defined as a 1 point increase from baseline on EDSS score if baseline EDSS was between 0 and 5.0, or a 0.5 point increase if baseline EDSS was 5.5, confirmed 3 months later. 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 confirmed progression (number of participants with confirmed progression of EDSS) sustained for 3 months. Progression could not be confirmed during a relapse.
Other	Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Scores	Baseline, Month 6, Month 12, Month 18, Month 24	The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Other	Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Mental Component Summary (MCS) Scores	Baseline, Month 6, Month 12, Month 18, Month 24	The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Other	Cumulative Number of New or Enlarging Hypointense Lesions on Enhanced T1 Scans	Months 12 and 24	The cumulative number of new or enlarging hypointense lesions was calculated as the sum of the numbers of new or enlarging hypointense lesions observed on scans taken at Months 12 and 24.
Other	Cumulative Number of Enhancing Lesions on T1-Weighted Images	Months 12 and 24	The cumulative number of T1 Gadolinium (Gd)-enhancing lesions was calculated as the sum of the numbers of Gd-enhancing lesions observed on scans taken at Months 12 and 24.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annualized Rate of Confirmed Relapses	Baseline up to Month 24	ITT analysis set included all randomized participants.	relapse per year	MEAN
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. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	Z score	MEAN
SECONDARY	Percent Change From Baseline in Brain Volume	Baseline, Month 24	ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	Percent Change	MEAN
SECONDARY	Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS	Baseline up to Month 24	ITT analysis set included all randomized participants.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Scores	Baseline, Month 6, Month 12, Month 18, Month 24	ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	MEAN
OTHER_PRE_SPECIFIED	Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Mental Component Summary (MCS) Scores	Baseline, Month 6, Month 12, Month 18, Month 24	ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	MEAN
OTHER_PRE_SPECIFIED	Cumulative Number of New or Enlarging Hypointense Lesions on Enhanced T1 Scans	Months 12 and 24	ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	lesions	MEAN
OTHER_PRE_SPECIFIED	Cumulative Number of Enhancing Lesions on T1-Weighted Images	Months 12 and 24	ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	lesions	MEAN

Source ClinicalTrials.gov

Results by group42

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

Outcome	Group	Value	Spread	Units
Annualized Rate of Confirmed Relapses	Placebo	0.344	95% Confidence Interval 0.291 to 0.406	relapse per year
Annualized Rate of Confirmed Relapses	Laquinimod	0.283	95% Confidence Interval 0.237 to 0.337	relapse per year
Annualized Rate of Confirmed Relapses	Avonex®	0.255	95% Confidence Interval 0.213 to 0.304	relapse per year
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	Placebo	-0.5	Standard Deviation 0.85	Z score
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	Laquinimod	-0.00	Standard Deviation 0.85	Z score
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	Avonex®	-0.01	Standard Deviation 0.75	Z score
Percent Change From Baseline in Brain Volume	Placebo	-0.53	Standard Deviation 0.65	Percent Change
Percent Change From Baseline in Brain Volume	Laquinimod	-0.51	Standard Deviation 0.65	Percent Change
Percent Change From Baseline in Brain Volume	Avonex®	-0.53	Standard Deviation 0.65	Percent Change
Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS	Placebo	60		Participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	450
Overall Study	STARTED	Laquinimod	434
Overall Study	STARTED	Avonex®	447
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	449
Overall Study	Received at Least 1 Dose of Study Drug	Laquinimod	433
Overall Study	Received at Least 1 Dose of Study Drug	Avonex®	442
Overall Study	COMPLETED	Placebo	359
Overall Study	COMPLETED	Laquinimod	353
Overall Study	COMPLETED	Avonex®	378
Overall Study	NOT COMPLETED	Placebo	91

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events321

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	Influenza like illness	General disorders	Placebo	7	449	7
other	Influenza like illness	General disorders	Laquinimod	5	433	5
other	Influenza like illness	General disorders	Avonex®	206	442	385
other	Pyrexia	General disorders	Placebo	7	449	10
other	Pyrexia	General disorders	Laquinimod	6	433	7
other	Pyrexia	General disorders	Avonex®	52	442	77
other	Influenza	Infections and infestations	Placebo	28	449	32
other	Influenza	Infections and infestations	Laquinimod	27	433	30
other	Influenza	Infections and infestations	Avonex®	20	442	30
other	Nasopharyngitis	Infections and infestations	Placebo	35	449	45

1 to 10 of 321Source ClinicalTrials.gov

See all 321 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	449
Total, all-cause mortality	Laquinimod	1	433
Total, all-cause mortality	Avonex®	1	442
Total, other adverse events	Placebo	146	449
Total, other adverse events	Laquinimod	158	433
Total, other adverse events	Avonex®	286	442
Total, serious adverse events	Placebo	36	449
Total, serious adverse events	Laquinimod	31	433
Total, serious adverse events	Avonex®	25	442

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26000222	DERIVED	PubMed
36163349	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 comparisons0

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

None in this release.

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/NCT00605215

GET https://conductscience.org/api/trials/v1/NCT00605215/results?page=2

API reference For AI assistants