Stopped earlyPhase 3Relapsing MSNCT009880522009-012989-30

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 7.64 years

GroupValueIntervalNumber analysed
Early Laquinimod375 Participants423
Switch From Placebo374 Participants416
Early Laquinimod76 Participants423
Switch From Placebo69 Participants416
Early Laquinimod109 Participants423
Switch From Placebo105 Participants416
Early Laquinimod139 Participants423
Switch From Placebo153 Participants416
Early Laquinimod3 Participants423
Switch From Placebo3 Participants416
Early Laquinimod108 Participants423
Switch From Placebo92 Participants416
Early Laquinimod35 Participants423
Switch From Placebo32 Participants416

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Early Laquinimod 0.6 mg423108 (25.5%)3
Switch From Placebo to Laquinimod 0.6 mg41692 (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

    Safety
  • There 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

    Safety
  • Participants 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

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    Related trials

    History

      1. Started

        Nov 2009

      2. Main results due

        Jul 2017

      3. Finished

        Jul 2017

      4. Results posted

        Jan 2019

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