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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00988052
First received: September 28, 2009
Last updated: July 29, 2014
Last verified: July 2014
  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 (RMS)
Drug: Laquinimod
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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


Secondary Outcome Measures:
  • Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of subjects who prematurely discontinue and time to withdrawal.

  • Long-term effect on disease course [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Long-term effect on disease course as measured by number of relapses and progression of physical disability


Enrollment: 844
Study Start Date: November 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

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 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).

One capsule containing 0.6 mg laquinimod to be administered orally once daily.

-To assess the long-term safety and tolerability of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

Safety and Tolerability Outcome Measures:

Safety:

  • Adverse events
  • Vital signs
  • ECG findings
  • Clinical laboratory parameters

Tolerability:

  • Proportion of subjects (%) who prematurely discontinued from the study, reason of discontinuation and the time to withdrawal.
  • Proportion of subjects (%) who prematurely discontinued from the study due to AEs and the time to withdrawal
  • To assess the long-term effect of laquinimod 0.6 mg on disease course, as assessed by several parameters:
  • Number of confirmed relapses
  • Progression of disability as measured by the EDSS score (including FS and AI)
  • Progression of disability as measured by the MSFC score
  • Binocular low-contrast visual acuity using the 100%, 2.5% and 1.25% contrast level charts [Sloan letter (Appendix 9) or Tumbling-E (Appendix 10)]
  • Subject-reported fatigue as assessed by the Modified Fatigue Impact Scale (MFIS)
  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: NCT00988052

  Show 135 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Giancarlo Comi, Prof., MD U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00988052     History of Changes
Other Study ID Numbers: MS-LAQ-301E, 2009-012989-30
Study First Received: September 28, 2009
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
European Union: European Medicines Agency
France: Ministry of Health
Georgia: Ministry of Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Bulgaria: Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Teva Pharmaceutical Industries:
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

ClinicalTrials.gov processed this record on September 18, 2014