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

NCT01404117 | Withdrawn Phase 2

• 1 other identifier: LAQ-MS-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy

  To assess the safety, tolerability and efficacy of laquinimod in RRMS

  10 months

Secondary Outcomes (1)

• Tolerability

  10 months

Study Arms (3)

Laquinimod 0.6

EXPERIMENTAL

GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg

Drug: Laquinimod 0.6

Laquinimod 1.2

EXPERIMENTAL

GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 1.2 mg

Drug: Laquinimod 1.2

GA or IFN + Placebo

EXPERIMENTAL

GA 20 mg/1mL or an IFN-B preparation + oral daily placebo

Other: Glatiramer Acetate or interferon-beta+ Placebo

Interventions

Laquinimod 0.6 DRUG

Laquinimod 0.6 capsule

Laquinimod 0.6

Laquinimod 1.2 DRUG

Placebo

Laquinimod 1.2

Glatiramer Acetate or interferon-beta+ Placebo OTHER

GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo

GA or IFN + Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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):

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Interventions

Glatiramer Acetate

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ralf Gold, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 27, 2013

Record last verified: 2013-08