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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
  Purpose
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).

Condition Intervention Phase
Multiple Sclerosis Drug: Laquinimod Drug: Matching Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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) ]

Other Outcome Measures:
  • 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) ]

Enrollment: 2199
Actual Study Start Date: February 28, 2013
Study Completion Date: April 19, 2017
Primary Completion Date: March 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Drug: Laquinimod
Placebo Comparator: Placebo
Two capsules containing placebo (matching to the 0.6 mg) to be administered orally once daily during Period 1.
Drug: Matching Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707992


  Show 215 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01707992     History of Changes
Other Study ID Numbers: LAQ-MS-305
First Submitted: September 28, 2012
First Posted: October 16, 2012
Last Update Posted: May 17, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases