Trial record 1 of 2 for:    MS-LAQ-301
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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: October 29, 2014
Last verified: October 2014

September 28, 2009
October 29, 2014
November 2009
October 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Safety measurement: Adverse events, vital signs, ECG findings, clinical laboratory parameters
Safety measurement: Adverse events, vital signs, ECG findings, clinical laboratory parameters [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00988052 on ClinicalTrials.gov Archive Site
  • 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
  • Tolerability: proportion of subjects (%) reason for discontinuation [ 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing Multiple Sclerosis (RMS)
Drug: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Intervention: Drug: Laquinimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
844
October 2014
October 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Italy,   Spain,   Germany,   Austria,   United Kingdom,   France,   Netherlands,   Sweden,   Russian Federation,   Hungary,   Romania,   Poland,   Czech Republic,   Estonia,   Lithuania,   Ukraine,   Bulgaria,   Serbia,   Israel,   Georgia,   Turkey
 
NCT00988052
MS-LAQ-301E, 2009-012989-30
Yes
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Principal Investigator: Giancarlo Comi, Prof., MD U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Teva Pharmaceutical Industries
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP