A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability

Teva Branded Pharmaceutical Products R&D, Inc.0 sitesMarch 2012

ConditionsRelapsing Multiple Sclerosis

InterventionsLaquinimod 0.6 Laquinimod 1.2 Glatiramer Acetate or interferon-beta+ Placebo

DrugsLaquinimod 0.6 Laquinimod 1.2

Overview

Phase: Phase 2
Intervention: Laquinimod 0.6
Conditions: Relapsing Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary Endpoint: Safety and efficacy
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS) subjects

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

January 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have a documented MS diagnosis as defined by the Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course.
•Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit.
•Subjects must be relapse-free and in a stable neurological condition and free of corticosteroid treatment \[intravenous (IV), intramuscular (IM) and/or oral\] 30 days prior to screening (month -1).
•Subjects must be treated with either Copaxone® or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®), at a stable dose for at least 6 months prior to the screening visit (switching between IFN-B preparations during the 6 months prior to screening is allowed; switching between any IFN-B preparation and GA, or vice versa, is exclusionary).
•Subjects must have had experienced at least one documented relapse in the 36 weeks prior to randomization, with an incomplete recovery of the neurological functions as compared to pre-relapse status.
•Subjects must be between 18 and 55 years of age, inclusive.
•Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barrier method (condom or diaphragm with spermicide)\].
•Subjects must be able to sign and date a written informed consent prior to entering the study.
•Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria

•An onset of a relapse between Month -1 (Screening) and 0 (Baseline), unstable neurological condition or any treatment with corticosteroids \[intravenous (IV), intramuscular (IM) and/or oral\] or Adrenocorticotropic hormone.
•Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to Screening.
•Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
•Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod, and fingolimod (Gilenya®).
•Previous treatment with intravenous immunoglobulin (IVIG) within 2 months prior to screening visit.
•Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
•Previous total body irradiation or total lymphoid irradiation.
•Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
•Use of moderate/strong inhibitors of cytochrome P450 CYP3A4 within 2 weeks prior to the screening visit.
•Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.