- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404117
A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability
August 26, 2013 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laquinimod 0.6
GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg
|
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
|
Placebo
|
Experimental: GA or IFN + Placebo
GA 20 mg/1mL or an IFN-B preparation + oral daily placebo
|
GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and efficacy
Time Frame: 10 months
|
To assess the safety, tolerability and efficacy of laquinimod in RRMS
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability
Time Frame: 10 months
|
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®).
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ralf Gold, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (Estimate)
July 27, 2011
Study Record Updates
Last Update Posted (Estimate)
August 27, 2013
Last Update Submitted That Met QC Criteria
August 26, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-beta
- Glatiramer Acetate
- (T,G)-A-L
Other Study ID Numbers
- LAQ-MS-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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