Trial · NCT01707992
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01707992, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2019-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS). Trials, record NCT01707992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01707992
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
- NCT number
- NCT01707992
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,199 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Multiple Sclerosis
- Interventions
- Laquinimod, Placebo
- First posted
- 2012-10-16
- Last updated
- 2021-11-09
- Other registries' IDs
- eudract:2012-003647-30
- Results first posted
- 2019-03-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Baseline to Month 24 | 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 with CDP) sustained for 3 months. |
| Secondary | Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Baseline, Month 15 | Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug. |
| Secondary | Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Baseline to Month 24 | Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 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 an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse). |
| Secondary | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) | Baseline to Month 24 | Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months. |
| Secondary | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) | Baseline to Month 24 | Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months. |
| Other | Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs) | Baseline up to Month 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. |
| Other | Active-Treatment Phase: Number of Participants With AEs | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. |
| Other | Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline up to Week 24 | Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\>=) 120 beats per minute (bpm) and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 millimeters of mercury (mmHg) and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg. |
| Other | Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Clinically significant vital signs abnormalities included: Pulse rate: \>=120 bpm and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 mmHg and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg. |
| Other | Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters | Baseline, Endpoint (Month 24) | ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Baseline, Month 15 | The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs) | Baseline up to Month 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active-Treatment Phase: Number of Participants With AEs | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline up to Week 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters | Baseline, Endpoint (Month 24) | Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Placebo-Controlled Phase: Placebo | 73 | Participants | ||
| Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Placebo-Controlled Phase: Laquinimod 0.6 mg | 66 | Participants | ||
| Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Placebo-Controlled Phase: Laquinimod 1.2 mg | 69 | Participants | ||
| Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Placebo-Controlled Phase: Placebo | -0.8 | Standard Deviation 1.02 | percent change | |
| Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Placebo-Controlled Phase: Laquinimod 0.6 mg | -0.4 | Standard Deviation 1.01 | percent change | |
| Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Placebo-Controlled Phase: Laquinimod 1.2 mg | -0.4 | Standard Deviation 1.05 | percent change | |
| Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Placebo-Controlled Phase: Placebo | 332 | Participants | ||
| Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Placebo-Controlled Phase: Laquinimod 0.6 mg | 269 | Participants | ||
| Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Placebo-Controlled Phase: Laquinimod 1.2 mg | 222 | Participants | ||
| Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) | Placebo-Controlled Phase: Placebo | 49 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Phase (24 Months) | STARTED | Placebo-Controlled Phase: Placebo | 740 | |
| Placebo-Controlled Phase (24 Months) | STARTED | Placebo-Controlled Phase: Laquinimod 0.6 mg | 727 | |
| Placebo-Controlled Phase (24 Months) | STARTED | Placebo-Controlled Phase: Laquinimod 1.2 mg | 732 | |
| Placebo-Controlled Phase (24 Months) | STARTED | Active Treatment Phase: Laquinimod 0.6 mg | 0 | |
| Placebo-Controlled Phase (24 Months) | STARTED | Active Treatment Phase: Laquinimod 1.2 mg | 0 | |
| Placebo-Controlled Phase (24 Months) | STARTED | Active Treatment Phase: Off Drug | 0 | |
| Placebo-Controlled Phase (24 Months) | COMPLETED | Placebo-Controlled Phase: Placebo | 596 | |
| Placebo-Controlled Phase (24 Months) | COMPLETED | Placebo-Controlled Phase: Laquinimod 0.6 mg | 623 | |
| Placebo-Controlled Phase (24 Months) | COMPLETED | Placebo-Controlled Phase: Laquinimod 1.2 mg | 532 | |
| Placebo-Controlled Phase (24 Months) | COMPLETED | Active Treatment Phase: Laquinimod 0.6 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,712
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 | Anaemia | Blood and lymphatic system disorders | Placebo-Controlled Phase: Laquinimod 0.6 mg | 28 | 727 | 32 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo-Controlled Phase: Laquinimod 1.2 mg | 43 | 732 | 50 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo-Controlled Phase: Placebo | 30 | 740 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | Active Treatment Phase: Early Laquinimod 0.6 mg | 22 | 580 | 25 |
| other | Anaemia | Blood and lymphatic system disorders | Active Treatment Phase: Early Laquinimod 1.2 mg | 13 | 268 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Active Treatment Phase: Off Drug | 7 | 215 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Active Treatment Phase: From Placebo to Laquinimod 0.6 mg | 9 | 311 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Active Treatment Phase: From Placebo to Laquinimod 1.2 mg | 9 | 236 | 12 |
| other | Nasopharyngitis | Infections and infestations | Placebo-Controlled Phase: Laquinimod 0.6 mg | 63 | 727 | 90 |
| other | Nasopharyngitis | Infections and infestations | Placebo-Controlled Phase: Laquinimod 1.2 mg | 60 | 732 | 86 |
1 to 10 of 1,712Source ClinicalTrials.gov
See all 1,712 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Controlled Phase: Laquinimod 0.6 mg | 1 | 727 |
| Total, all-cause mortality | Placebo-Controlled Phase: Laquinimod 1.2 mg | 1 | 732 |
| Total, all-cause mortality | Placebo-Controlled Phase: Placebo | 2 | 740 |
| Total, all-cause mortality | Active Treatment Phase: Early Laquinimod 0.6 mg | 2 | 580 |
| Total, all-cause mortality | Active Treatment Phase: Early Laquinimod 1.2 mg | 0 | 268 |
| Total, all-cause mortality | Active Treatment Phase: Off Drug | 0 | 215 |
| Total, all-cause mortality | Active Treatment Phase: From Placebo to Laquinimod 0.6 mg | 0 | 311 |
| Total, all-cause mortality | Active Treatment Phase: From Placebo to Laquinimod 1.2 mg | 0 | 236 |
| Total, other adverse events | Placebo-Controlled Phase: Laquinimod 0.6 mg | 262 | 727 |
| Total, other adverse events | Placebo-Controlled Phase: Laquinimod 1.2 mg | 286 | 732 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34378456 | DERIVED |
Source 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry | Trial comparisons |
Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values | Trial comparisons |
| Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active-Treatment Phase: Number of Participants With AEs | Trial comparisons |
| Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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