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A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

This study has been terminated.
(Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988052
First Posted: October 1, 2009
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
  Purpose
The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

Condition Intervention Phase
Relapsing Multiple Sclerosis Drug: Laquinimod Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):

Primary Outcome Measures:
  • Safety [ Time Frame: 3 years ]
    Safety measurement: Adverse events, vital signs, ECG findings, clinical laboratory parameters


Secondary Outcome Measures:
  • Tolerability [ Time Frame: 3 years ]
    Proportion of subjects who prematurely discontinue and time to withdrawal.

  • Long-term effect on disease course [ Time Frame: 3 years ]
    Long-term effect on disease course as measured by number of relapses and progression of physical disability


Enrollment: 472
Actual Study Start Date: November 30, 2009
Study Completion Date: May 9, 2017
Primary Completion Date: May 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Drug: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
  2. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the study and up to 30 days after the last dose of the study drug..
  3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.

Exclusion Criteria:

  1. Premature discontinuation from the MS-LAQ-301 study, for any reason.
  2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
  3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
  4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988052


  Show 133 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Investigators
Principal Investigator: Giancarlo Comi, Prof., MD U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
  More Information

Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT00988052     History of Changes
Other Study ID Numbers: MS-LAQ-301E
2009-012989-30 ( EudraCT Number )
First Submitted: September 28, 2009
First Posted: October 1, 2009
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Disease Progression
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes