Stopped earlyPhase 3Relapsing MSNCT010473192009-015815-42

What it found

Stopped early

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

GroupValueIntervalNumber analysed
Early Laquinimod290 Participants345
Switch From Placebo303 Participants350
Switch From Avonex279 Participants352
Early Laquinimod54 Participants345
Switch From Placebo65 Participants350
Switch From Avonex51 Participants352
Early Laquinimod36 Participants345
Switch From Placebo54 Participants350
Switch From Avonex44 Participants352
Early Laquinimod20 Participants345
Switch From Placebo28 Participants350
Switch From Avonex23 Participants352
Early Laquinimod66 Participants345
Switch From Placebo64 Participants350
Switch From Avonex73 Participants352
Early Laquinimod66 Participants345
Switch From Placebo76 Participants350
Switch From Avonex96 Participants352
Early Laquinimod5 Participants345
Switch From Placebo3 Participants350
Switch From Avonex5 Participants352

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Early Laquinimod34554 (15.7%)5
Switch From Placebo35065 (18.6%)3
Switch From Avonex35251 (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

    Safety
  • There 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

    Safety
  • Participants 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

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    History

      1. Started

        May 2010

      2. Main results due

        Jun 2017

      3. Finished

        Jun 2017

      4. Results posted

        Jan 2019

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