Status:
WITHDRAWN
A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Use of amiodarone within 2 years prior to screening visit.
- Pregnancy or breastfeeding.
- A ≥3xULN serum elevation of either alanine transaminase (ALT) or aspartate transaminase (AST) at screening.
- Serum direct bilirubin which is ≥2x upper limit of normal (ULN) at screening.
- Subjects with a potentially clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include (but are not limited to):
- A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
- A gastrointestinal disorder that may affect the absorption of study medication.
- Renal or metabolic diseases
- Any form of acute or chronic liver disease
- Known human immunodeficiency virus (HIV) positive status
- A history of drug and/or alcohol abuse
- An unstable psychiatric disorder.
- A known history of tuberculosis.
- Unstable psychiatric disorder
- Any malignancies, excluding basal cell carcinoma (BCC), in the last 5 years.
- A glomerular filtration rate less than 60 ml/min at screening visit.
- A known history of sensitivity to gadolinium (Gd).
- Inability to successfully undergo MRI scanning.
- Previous endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
- Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01404117
Start Date
March 1 2012
End Date
January 1 2014
Last Update
August 27 2013
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