Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relapse Rate: Number of Confirmed Relapses During the Double Blind Study PeriodPrimary· 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
Group
Value
95% CI
Laquinimod
0.54
± 0.88
Placebo
0.67
± 0.92
Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI ImagesSecondary· 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.
Group
Value
95% CI
Laquinimod
1.86
± 5.02
Placebo
2.92
± 7.58
Composite Endpoint: Sum of the Number of New/Enlarging T2 LesionsSecondary· Month 12, Month 24
Composite score calculated as the sum of T2 lesions at Months 12 and 24 that are new or enlarged.
Group
Value
95% CI
Laquinimod
5.26
± 9.08
Placebo
7.87
± 12.56
Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)Secondary· 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 p
Group
Value
95% CI
Laquinimod
54
Placebo
78
Laquinimod
496
Placebo
478
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) ScoreSecondary· 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 t
Group
Value
95% CI
Laquinimod
0.0
± 0.4
Placebo
0.0
± 0.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to 24 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Laquinimod 0.6 mg
Serious: 61/550 (11%)
Deaths: 0/550
Placebo
Serious: 53/556 (10%)
Deaths: 3/556
Serious adverse events (156 terms)
Reaction
System
Laquinimod 0.6 mg
Placebo
Appendicitis
Infections and infestations
—
—
Multiple sclerosis relapse
Nervous system disorders
—
—
Hysterectomy
Surgical and medical procedures
—
—
Chest pain
General disorders
—
—
Rehabilitation therapy
Surgical and medical procedures
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Gastritis
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Cholelithiasis
Hepatobiliary disorders
—
—
Cellulitis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05187403 — A Study of Laquinimod Eye-drops in Healthy Participants
· Phase 1
· completed
NCT02284568 — A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tole
· Phase 2
· completed
NCT02215616 — A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laq
· Phase 2
· completed
NCT01707992 — The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
· Phase 3
· completed
NCT01085084 — A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 2 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00509145.