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Trial record 1 of 1 for:    laq-ms-305
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The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707992
First Posted: October 16, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
September 28, 2012
October 16, 2012
May 17, 2017
February 28, 2013
March 9, 2017   (Final data collection date for primary outcome measure)
Time to Confirmed Disease Progression (CDP) after at least 3 months in Period 1 [ Time Frame: 24 months (Period 1) ]
CDP is defined as an increase in Expanded Disability Status Scale (EDSS)
Time to Confirmed Disease Progression (CDP) in Period 1 [ Time Frame: 24 months (Period 1) ]
CDP is defined as an increase in Kurtzke's Expanded Disability Status Scale (EDSS) of 1 point or more from baseline for subjects with baseline EDSS of ≤5.0, or an increase 0.5 points or more from baseline for subjects with baseline EDSS of 5.5. The EDSS rates a person's disability due to multiple sclerosis severity, ranging from 0 (normal neurological exam) to 10 (death due to MS). The higher score represents more severe disability. The outcome measure is the time recorded from Baseline until the subject meets this definition of CDP.
Complete list of historical versions of study NCT01707992 on ClinicalTrials.gov Archive Site
  • Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ]
    This is a measure of brain volume and will be assessed by an MRI. Brain atrophy is defined as the percent change in brain volume from baseline to month 15
  • The time to first confirmed relapse during Period 1 [ Time Frame: 24 months (Period 1) ]
  • Time to CDP confirmed after at least 6 months [ Time Frame: 24 months (Period 1) ]
  • Time to CDP confirmed after at least 9 months [ Time Frame: 24 months (Period 1) ]
Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ]
This is a measure of brain volume and will be assessed by an MRI. Brain atrophy is defined as the percent change in brain volume from baseline to month 15
  • Number of Participants with Adverse Events [ Time Frame: 24 months (Period 1) ]
  • Number of Participants with Abnormal Vital Signs [ Time Frame: 24 months (Period 1) ]
  • Number of Participants with Abnormal ECG Findings [ Time Frame: 24 months (Period 1) ]
  • Number of Participants with Abnormal Clinical Laboratory Parameters [ Time Frame: 24 months (Period 1) ]
Same as current
 
The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod (0.6 mg/d or 1.2 mg/d) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Laquinimod
  • Drug: Matching Placebo
  • Experimental: Laquinimod Dose 0.6 mg
    Two capsules, one containing 0.6 mg laquinimod and the other containing matching placebo, to be administered orally once daily during both Periods 1 and 2.
    Intervention: Drug: Laquinimod
  • Experimental: Laquinimod Dose 1.2 mg

    Two capsules containing 0.6 mg laquinimod to be administered orally once daily during both Periods 1 and 2.

    NOTE- As of January 2016, this arm has been discontinued.

    Intervention: Drug: Laquinimod
  • Placebo Comparator: Placebo
    Two capsules containing placebo (matching to the 0.6 mg) to be administered orally once daily during Period 1.
    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2199
April 19, 2017
March 9, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
  • Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
  • Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
  • Subjects must have disease duration of not more than 15 years.
  • Women of child-bearing potential (for example women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication o Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Subjects with progressive forms of MS.
  • Subjects with Neuromyelitis Optica (NMO).
  • Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to randomization.
  • Use of immunosuppressive agents,or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization.
  • Use of either of the following within 2 years prior to screening visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
  • Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.
  • Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulin (IVIG) within 2 months prior to randomization.
  • Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
  • Previous use of Mitoxantrone (Novantrone®), Cladribine, or alemtuzumab (Lemtrada®).
  • Previous use of laquinimod.
  • Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization.
  • Use of inducers of CYP3A4 within 2 weeks prior to randomization.
  • Pregnancy or breastfeeding.
  • A known history of sensitivity to gadolinium (Gd).
  • Inability to successfully undergo MRI scanning.
  • Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization.

    • Additional criteria apply, please contact the investigator for more information
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belarus,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Georgia,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Montenegro,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Ukraine,   United Kingdom,   United States
Belgium,   Czech Republic,   Kazakhstan,   Mexico,   Portugal
 
NCT01707992
LAQ-MS-305
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Director: Teva Medical Expert, MD TEVA
Teva Pharmaceutical Industries
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP