Trial record 1 of 2 for:    MS-LAQ-301
Previous Study | Return to List | Next Study

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

  Hide Study Locations
Locations
United States, Arizona
Teva Investigational Site 1076
Phoenix, Arizona, United States
United States, Colorado
Teva Investigational Site 1090
Centennial, Colorado, United States
Teva Investigational Site 1088
Fort Collins, Colorado, United States
United States, Illinois
Teva Investigational Site 1102
Northbrook, Illinois, United States
United States, Indiana
Teva Investigational Site 1081
Fort Wayne, Indiana, United States
United States, Iowa
Teva Investigational Site 1083
Des Moines, Iowa, United States
United States, Kansas
Teva Investigational Site 1086
Kansas City, Kansas, United States
United States, Kentucky
Teva Investigational Site 1101
Lexington, Kentucky, United States
United States, Michigan
Teva Investigational Site 1096
Farmington Hills, Michigan, United States
United States, Minnesota
Teva Investigational Site 1093
Minneapolis, Minnesota, United States
United States, Missouri
Teva Investigational Site 1080
Chesterfield, Missouri, United States
Teva Investigational Site 1098
St. Louis, Missouri, United States
United States, New York
Teva Investigational Site 1082
New York, New York, United States
United States, North Carolina
Teva Investigational Site 1073
Winston-Salem, North Carolina, United States
United States, North Dakota
Teva Investigational Site 1097
Fargo, North Dakota, United States
United States, Ohio
Teva Investigational Site 1084
Dayton, Ohio, United States
United States, Oklahoma
Teva Investigational Site 1092
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Teva Investigational Site 1100
Hershey, Pennsylvania, United States
United States, Texas
Teva Investigational Site 1075
Lubbock, Texas, United States
Teva Investigational Site 1078
San Antonio, Texas, United States
United States, Wisconsin
Teva Investigational Site 1085
Milwaukee, Wisconsin, United States
Austria
Teva Investigational Site 3300
Klagenfurt, Austria
Teva Investigational Site 3303
Linz, Austria
Teva Investigational Site 3302
St. Poelten, Austria
Bulgaria
Teva Investigational Site 5901
Pleven, Bulgaria
Teva Investigational Site 5903
Sofia, Bulgaria
Teva Investigational Site 5904
Sofia, Bulgaria
Teva Investigational Site 5900
Sofia, Bulgaria
Teva Investigational Site 5905
Sofia, Bulgaria
Teva Investigational Site 5902
Varna, Bulgaria
Canada, Nova Scotia
Teva Investigational Site 1132
Halifax, Nova Scotia, Canada
Canada, Ontario
Teva Investigational Site 1126
London, Ontario, Canada
Teva Investigational Site 1128
Ottawa, Ontario, Canada
Teva Investigational Site 1134
Toronto, Ontario, Canada
Canada, Quebec
Teva Investigational Site 1130
Greenfield Park, Quebec, Canada
Teva Investigational Site 1129
Montréal, Quebec, Canada
Teva Investigational Site 1131
Sherbrooke, Quebec, Canada
Czech Republic
Teva Investigational Site 5417
Olomouc, Czech Republic
Teva Investigational Site 5416
Ostrava - poruba, Czech Republic
Estonia
Teva Investigational Site 5504
Tallinn, Estonia
Teva Investigational Site 5505
Tartu, Estonia
France
Teva Investigational Site 3525
Besancon, France
Teva Investigational Site 3527
Bron Cedex, France
Teva Investigational Site 3526
Clermont-Ferrand Cedex 1, France
Teva Investigational Site 3524
Lille Cedex, France
Teva Investigational Site 3528
Marseille Cedex 5, France
Teva Investigational Site 3529
Rennes Cedex 9, France
Georgia
Teva Investigational Site 8100
Tbilisi, Georgia
Teva Investigational Site 8101
Tbilisi, Georgia
Germany
Teva Investigational Site 3247
Bayreuth, Germany
Teva Investigational Site 3238
Berlin, Germany
Teva Investigational Site 3241
Berlin, Germany
Teva Investigational Site 3248
Bochum, Germany
Teva Investigational Site 3245
Dresden, Germany
Teva Investigational Site 3237
Emden, Germany
Teva Investigational Site 3242
Erbach, Germany
Teva Investigational Site 3240
Erfurt, Germany
Teva Investigational Site 3249
Freiburg, Germany
Teva Investigational Site 3236
Hamburg, Germany
Teva Investigational Site 3239
Hannover, Germany
Teva Investigational Site 3243
Heidelberg, Germany
Teva Investigational Site 3251
Muenster, Germany
Teva Investigational Site 3250
Trier, Germany
Teva Investigational Site 3244
Ulm, Germany
Hungary
Teva Investigational Site 5115
Budapest, Hungary
Teva Investigational Site 5114
Debrecen, Hungary
Teva Investigational Site 5116
Miskolc, Hungary
Teva Investigational Site 5117
Veszprem, Hungary
Israel
Teva Investigational Site 8033
Tel Hashomer, IL, Israel
Teva Investigational Site 8031
Haifa, Israel
Teva Investigational Site 8030
Jerusalem, Israel
Teva Investigational Site 8032
Tel Aviv, Israel
Italy
Teva Investigational Site 3044
Catania, Italy
Teva Investigational Site 3042
Gallarate (Varese), Italy
Teva Investigational Site 3046
Grosseto, Italy
Teva Investigational Site 3045
Località Vaio - Fidenza (PR), Italy
Teva Investigational Site 3039
Milano, Italy
Teva Investigational Site 3038
Milano, Italy
Teva Investigational Site 555
Milano, Italy
Teva Investigational Site 3041
Palermo, Italy
Teva Investigational Site 3040
Roma, Italy
Lithuania
Teva Investigational Site 5704
Kaunas, Lithuania
Teva Investigational Site 5705
Siauliai, Lithuania
Netherlands
Teva Investigational Site 3810
Nieuwegein, Netherlands
Teva Investigational Site 3809
Nijmegen, Netherlands
Poland
Teva Investigational Site 5322
Czestochowa, Poland
Teva Investigational Site 5320
Gorzow Wielkopolski, Poland
Teva Investigational Site 5316
Katowice, Poland
Teva Investigational Site 5318
Kielce, Poland
Teva Investigational Site 5319
Konskie, Poland
Teva Investigational Site 5317
Krakow, Poland
Teva Investigational Site 5315
Lodz, Poland
Teva Investigational Site 5325
Warszawa, Poland
Romania
Teva Investigational Site 5208
Bucharest, Romania
Teva Investigational Site 5210
Cluj-Napoca, Romania
Teva Investigational Site 5212
Constanta, Romania
Teva Investigational Site 5211
Targu-Mures, Romania
Teva Investigational Site 5209
Timisoara, Romania
Russian Federation
Teva Investigational Site 5029
Ekaterinburg, Russian Federation
Teva Investigational Site 5021
Moscow, Russian Federation
Teva Investigational Site 5028
Nizhny Novgorod, Russian Federation
Teva Investigational Site 5027
Novosibirsk, Russian Federation
Teva Investigational Site 5030
Perm, Russian Federation
Teva Investigational Site 5022
Saint Petersburg, Russian Federation
Teva Investigational Site 5023
St. Petersburg, Russian Federation
Teva Investigational Site 5025
St. Petersburg, Russian Federation
Teva Investigational Site 5024
St. Petersburg, Russian Federation
Teva Investigational Site 5026
St.Petersburg, Russian Federation
Serbia
Teva Investigational Site 6100
Belgrade, Serbia
Teva Investigational Site 6102
Nis, Serbia
Spain
Teva Investigational Site 3132
Barcelona, Spain
Teva Investigational Site 3144
Barcelona, Spain
Teva Investigational Site 3134
Barcelona, Spain
Teva Investigational Site 3136
Girona, Spain
Teva Investigational Site 3135
Lleida, Spain
Teva Investigational Site 3142
Madrid, Spain
Teva Investigational Site 3146
Madrid, Spain
Teva Investigational Site 3133
Madrid, Spain
Teva Investigational Site 3137
Murcia, Spain
Teva Investigational Site 3138
Pontevedra, Spain
Teva Investigational Site 3139
Santiago de Compostela, Spain
Teva Investigational Site 3143
Valencia, Spain
Teva Investigational Site 3140
Vigo, Spain
Sweden
Teva Investigational Site 4204
Stockholm, Sweden
Teva Investigational Site 4205
Stockholm, Sweden
Teva Investigational Site 4206
Stockholm, Sweden
Turkey
Teva Investigational Site 8201
Izmir, Turkey
Ukraine
Teva Investigational Site 5803
Dnipropetrovsk, Ukraine
Teva Investigational Site 5802
Kyiv, Ukraine
Teva Investigational Site 5804
Kyiv, Ukraine
Teva Investigational Site 5800
Lviv, Ukraine
Teva Investigational Site 5801
Vinnytsya, Ukraine
United Kingdom
Teva Investigational Site 3425
Liverpool, United Kingdom
Teva Investigational Site 3424
London, United Kingdom
Teva Investigational Site 3422
Sheffield, United Kingdom
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