-
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 7.13 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Early Laquinimod | 290 Participants | 345 | |
| Switch From Placebo | 303 Participants | 350 | |
| Switch From Avonex | 279 Participants | 352 | |
| Early Laquinimod | 54 Participants | 345 | |
| Switch From Placebo | 65 Participants | 350 | |
| Switch From Avonex | 51 Participants | 352 | |
| Early Laquinimod | 36 Participants | 345 | |
| Switch From Placebo | 54 Participants | 350 | |
| Switch From Avonex | 44 Participants | 352 | |
| Early Laquinimod | 20 Participants | 345 | |
| Switch From Placebo | 28 Participants | 350 | |
| Switch From Avonex | 23 Participants | 352 | |
| Early Laquinimod | 66 Participants | 345 | |
| Switch From Placebo | 64 Participants | 350 | |
| Switch From Avonex | 73 Participants | 352 | |
| Early Laquinimod | 66 Participants | 345 | |
| Switch From Placebo | 76 Participants | 350 | |
| Switch From Avonex | 96 Participants | 352 | |
| Early Laquinimod | 5 Participants | 345 | |
| Switch From Placebo | 3 Participants | 350 | |
| Switch From Avonex | 5 Participants | 352 |
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 | 345 | 54 (15.7%) | 5 |
| Switch From Placebo | 350 | 65 (18.6%) | 3 |
| Switch From Avonex | 352 | 51 (14.5%) | 5 |
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 7.13 years
SafetyThere is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature. Summary statistics will be prepared for demographic, safety and efficacy variables.
Safety
Other measures (5)
Participants With Potentially Clinically Significant Abnormal Vital Signs
Baseline (Day 0 for extension), Day 1 up to 7.13 years
SafetyParticipants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Baseline (Day 0), Day 1 to 7.13 years
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Baseline (Day 0), Day 1 to 7.13 years
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Baseline (Day 0), Day 1 to 7.13 years
Not applicable
Who could take part
Relapsing MS
Inclusion Criteria: 1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 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-302E study. Exclusion Criteria: 1. Premature discontinuation from the MS-LAQ-302 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-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E 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
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 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…
Related trials
- LTS18002
Phase 3 · Not yet recruiting
Still running
- FREXALT
Phase 3 · Running, not recruiting
Still running
- LITMUS
Not a drug-phase study · Completed (inferred)
Results posted, no main test reported
- Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS
Phase 2 · Stopped early
Stopped early
- SUSTAIN
Phase 3 · Stopped early
Stopped early
- ZEUS
Not a drug-phase study · Stopped
Stopped early
History
Started
May 2010
Main results due
Jun 2017
Finished
Jun 2017
Results posted
Jan 2019
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error