-
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
What was tested
Treatment tested
Results by group
Participants With Treatment-Emergent Adverse Events (TEAEs)
Day 1 up to 7.64 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Early Laquinimod | 375 Participants | 423 | |
| Switch From Placebo | 374 Participants | 416 | |
| Early Laquinimod | 76 Participants | 423 | |
| Switch From Placebo | 69 Participants | 416 | |
| Early Laquinimod | 109 Participants | 423 | |
| Switch From Placebo | 105 Participants | 416 | |
| Early Laquinimod | 139 Participants | 423 | |
| Switch From Placebo | 153 Participants | 416 | |
| Early Laquinimod | 3 Participants | 423 | |
| Switch From Placebo | 3 Participants | 416 | |
| Early Laquinimod | 108 Participants | 423 | |
| Switch From Placebo | 92 Participants | 416 | |
| Early Laquinimod | 35 Participants | 423 | |
| Switch From Placebo | 32 Participants | 416 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Early Laquinimod 0.6 mg | 423 | 108 (25.5%) | 3 |
| Switch From Placebo to Laquinimod 0.6 mg | 416 | 92 (22.1%) | 3 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Participants With Treatment-Emergent Adverse Events (TEAEs)
Day 1 up to 7.64 years
SafetyThere is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature.
Other measures (5)
Participants With Potentially Clinically Significant Abnormal Vital Signs
Day 1 up to 7.64 years
SafetyParticipants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Day 1 up to 7.64 years
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Day 1 up to 7.64 years
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Day 1 up to 7.64 years
not applicable
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: 1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol. 2. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the study and up to 30 days after the last dose of the study drug.. 3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study. Exclusion Criteria: 1. Premature discontinuation from the MS-LAQ-301 study, for any reason. 2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding. 3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study. 4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2009
Main results due
Jul 2017
Finished
Jul 2017
Results posted
Jan 2019
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