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

This study has been withdrawn prior to enrollment.
(Study is being redesigned)
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01404117
First received: July 26, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Laquinimod 0.6
Drug: Laquinimod 1.2
Other: Glatiramer Acetate or interferon-beta+ Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Safety and efficacy [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    To assess the safety, tolerability and efficacy of laquinimod in RRMS


Secondary Outcome Measures:
  • Tolerability [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    To assess the safety, tolerability and efficacy of laquinimod in RRMS as compared to placebo, subjects treated with GA or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®).


Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod 0.6
GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg
Drug: Laquinimod 0.6
Laquinimod 0.6 capsule
Experimental: Laquinimod 1.2
GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 1.2 mg
Drug: Laquinimod 1.2
Placebo
Experimental: GA or IFN + Placebo
GA 20 mg/1mL or an IFN-B preparation + oral daily placebo
Other: Glatiramer Acetate or interferon-beta+ Placebo
GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit.
  3. 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).
  4. 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).
  5. 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.
  6. Subjects must be between 18 and 55 years of age, inclusive.
  7. 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)].
  8. Subjects must be able to sign and date a written informed consent prior to entering the study.
  9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to Screening.
  3. Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
  4. Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod, and fingolimod (Gilenya®).
  5. Previous treatment with intravenous immunoglobulin (IVIG) within 2 months prior to screening visit.
  6. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
  7. Previous total body irradiation or total lymphoid irradiation.
  8. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  9. Use of moderate/strong inhibitors of cytochrome P450 CYP3A4 within 2 weeks prior to the screening visit.
  10. Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.
  11. Use of amiodarone within 2 years prior to screening visit.
  12. Pregnancy or breastfeeding.
  13. A ≥3xULN serum elevation of either alanine transaminase (ALT) or aspartate transaminase (AST) at screening.
  14. Serum direct bilirubin which is ≥2x upper limit of normal (ULN) at screening.
  15. 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.
  16. A glomerular filtration rate less than 60 ml/min at screening visit.
  17. A known history of sensitivity to gadolinium (Gd).
  18. Inability to successfully undergo MRI scanning.
  19. Previous endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
  20. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404117

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Ralf Gold, MD
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01404117     History of Changes
Other Study ID Numbers: LAQ-MS-201
Study First Received: July 26, 2011
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Copolymer 1
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014