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

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ClinicalTrials.gov Identifier: NCT00988052
Recruitment Status : Terminated (Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.)
First Posted : October 1, 2009
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

Brief Summary:
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 or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Laquinimod Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
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 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS
Actual Study Start Date : November 10, 2009
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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


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

  2. 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



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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).

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


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Locations
United States, Arizona
Teva Investigational Site 1076
Phoenix, Arizona, United States, 85004
United States, Colorado
Teva Investigational Site 1090
Centennial, Colorado, United States, 80112
Teva Investigational Site 1088
Fort Collins, Colorado, United States, 80528
United States, Illinois
Teva Investigational Site 1102
Northbrook, Illinois, United States, 60062
United States, Indiana
Teva Investigational Site 1081
Fort Wayne, Indiana, United States, 46845
United States, Iowa
Teva Investigational Site 1083
Des Moines, Iowa, United States, 50314
United States, Kansas
Teva Investigational Site 1086
Kansas City, Kansas, United States, 66103
United States, Kentucky
Teva Investigational Site 1101
Lexington, Kentucky, United States, 40513
United States, Minnesota
Teva Investigational Site 1093
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Teva Investigational Site 1098
Saint Louis, Missouri, United States, 63104
United States, New York
Teva Investigational Site 1082
New York, New York, United States, 10016
United States, North Carolina
Teva Investigational Site 1073
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Teva Investigational Site 1097
Fargo, North Dakota, United States, 58103
United States, Ohio
Teva Investigational Site 1084
Dayton, Ohio, United States, 45417
United States, Oklahoma
Teva Investigational Site 1092
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Teva Investigational Site 1100
Hershey, Pennsylvania, United States, 17033-0850
United States, Texas
Teva Investigational Site 1075
Lubbock, Texas, United States, 79410
Teva Investigational Site 1078
San Antonio, Texas, United States, 78231
United States, Wisconsin
Teva Investigational Site 1085
Milwaukee, Wisconsin, United States, 53215
Austria
Teva Investigational Site 3300
Klagenfurt, Austria, 9020
Teva Investigational Site 3303
Linz, Austria, A-4021
Teva Investigational Site 3302
St. Poelten, Austria, 3100
Bulgaria
Teva Investigational Site 5901
Pleven, Bulgaria, 5800
Teva Investigational Site 5904
Sofia, Bulgaria, 1113
Teva Investigational Site 5903
Sofia, Bulgaria, 1309
Teva Investigational Site 5900
Sofia, Bulgaria, 1606
Teva Investigational Site 5905
Sofia, Bulgaria, 1606
Teva Investigational Site 5902
Varna, Bulgaria, 9010
Canada, Nova Scotia
Teva Investigational Site 1132
Bedford, Nova Scotia, Canada, B4A 1A9
Canada, Ontario
Teva Investigational Site 1126
London, Ontario, Canada, N6A 5A5
Teva Investigational Site 1128
Ottawa, Ontario, Canada, K2G 6E2
Teva Investigational Site 1134
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Teva Investigational Site 1130
Greenfield Park, Quebec, Canada, J4V 2J2
Teva Investigational Site 1129
Montreal, Quebec, Canada, H1T 2M4
Teva Investigational Site 1131
Sherbrooke, Quebec, Canada, J1H 5N4
Czechia
Teva Investigational Site 5417
Olomouc, Czechia, 779 00
Teva Investigational Site 5416
Ostrava - poruba, Czechia, 708 52
Estonia
Teva Investigational Site 5504
Tallinn, Estonia, EE-10617
Teva Investigational Site 5505
Tartu, Estonia, EE-51014
France
Teva Investigational Site 3525
Besancon, France, 25030
Teva Investigational Site 3527
Bron, France, 69677
Teva Investigational Site 3526
Clermont-Ferrand Cedex 1, France, 63003
Teva Investigational Site 3524
Lille Cedex, France, 59037
Teva Investigational Site 3528
Marseille Cedex 5, France, 13385
Teva Investigational Site 3529
Rennes Cedex 9, France, 35033
Georgia
Teva Investigational Site 8100
Tbilisi, Georgia, 0112
Teva Investigational Site 8101
Tbilisi, Georgia, 0179
Germany
Teva Investigational Site 3247
Bayreuth, Germany, 95445
Teva Investigational Site 3241
Berlin, Germany, 10713
Teva Investigational Site 3238
Berlin, Germany, 13347
Teva Investigational Site 3248
Bochum, Germany, 44791
Teva Investigational Site 3245
Dresden, Germany, 01307
Teva Investigational Site 3237
Emden, Germany, 26721
Teva Investigational Site 3242
Erbach, Germany, 64711
Teva Investigational Site 3240
Erfurt, Germany, 99089
Teva Investigational Site 3249
Freiburg, Germany, 79106
Teva Investigational Site 3236
Hamburg, Germany, 20246
Teva Investigational Site 3239
Hannover, Germany, 30171
Teva Investigational Site 3243
Heidelberg, Germany, 69120
Teva Investigational Site 3251
Munster, Germany, 48149
Teva Investigational Site 3250
Trier, Germany, 54292
Teva Investigational Site 3244
Ulm, Germany, 89081
Hungary
Teva Investigational Site 5115
Budapest, Hungary, H-1145
Teva Investigational Site 5114
Debrecen, Hungary, 4043
Teva Investigational Site 5116
Miskolc, Hungary, 3526
Teva Investigational Site 5117
Veszprem, Hungary, H-8200
Israel
Teva Investigational Site 8031
Haifa, Israel, 3436212
Teva Investigational Site 8030
Jerusalem, Israel, 9112001
Teva Investigational Site 8033
Ramat Gan, Israel, 5262160
Teva Investigational Site 8032
Tel Aviv, Israel, 64239
Italy
Teva Investigational Site 3044
Catania, Italy, 95124
Teva Investigational Site 3045
Fidenza, Italy, 43036
Teva Investigational Site 3042
Gallarate, Italy, 21013
Teva Investigational Site 3046
Grosseto, Italy, 58100
Teva Investigational Site 3038
Milano, Italy, 20132
Teva Investigational Site 555
Milano, Italy, 20132
Teva Investigational Site 3039
Milano, Italy, 20148
Teva Investigational Site 3041
Palermo, Italy, 90146
Teva Investigational Site 3040
Rome, Italy, 00133
Lithuania
Teva Investigational Site 5704
Kaunas, Lithuania, 50009
Teva Investigational Site 5705
Siauliai, Lithuania, 76231
Netherlands
Teva Investigational Site 3810
Nieuwegein, Netherlands, 3430 EM
Teva Investigational Site 3809
Nijmegen, Netherlands, 6525 GC
Poland
Teva Investigational Site 5322
Czestochowa, Poland, 42-280
Teva Investigational Site 5320
Gorzow Wielkopolski, Poland, 66-400
Teva Investigational Site 5316
Katowice, Poland, 40-752
Teva Investigational Site 5318
Kielce, Poland, 25-726
Teva Investigational Site 5319
Konskie, Poland, 26-200
Teva Investigational Site 5317
Krakow, Poland, 31-826
Teva Investigational Site 5315
Lodz, Poland, 90-153
Teva Investigational Site 5325
Warszawa, Poland, 04-749
Romania
Teva Investigational Site 5208
Bucharest, Romania, 011461
Teva Investigational Site 5210
Cluj-Napoca, Romania, 400437
Teva Investigational Site 5212
Constanta, Romania, 900123
Teva Investigational Site 5211
Targu-Mures, Romania, 540136
Teva Investigational Site 5209
Timisoara, Romania, 300736
Russian Federation
Teva Investigational Site 5029
Ekaterinburg, Russian Federation, 620102
Teva Investigational Site 5021
Moscow, Russian Federation, 127015
Teva Investigational Site 5028
Nizhny Novgorod, Russian Federation, 603126
Teva Investigational Site 5027
Novosibirsk, Russian Federation, 630087
Teva Investigational Site 5030
Perm, Russian Federation, 614990
Teva Investigational Site 5022
Saint Petersburg, Russian Federation, 197022
Teva Investigational Site 5025
St. Petersburg, Russian Federation, 194044
Teva Investigational Site 5024
St. Petersburg, Russian Federation, 194354
Teva Investigational Site 5023
St. Petersburg, Russian Federation, 197376
Teva Investigational Site 5026
St.Petersburg, Russian Federation, 191186
Serbia
Teva Investigational Site 6100
Belgrade, Serbia, 11000
Teva Investigational Site 6102
Nis, Serbia, 18 000
Spain
Teva Investigational Site 3132
Barcelona, Spain, 08035
Teva Investigational Site 3134
Barcelona, Spain, 08036
Teva Investigational Site 3144
Barcelona, Spain, 08041
Teva Investigational Site 3140
Beade-Pontevedra, Spain, 36312
Teva Investigational Site 3142
Getafe, Spain, 28905
Teva Investigational Site 3135
Lleida, Spain, 25198
Teva Investigational Site 3133
Madrid, Spain, 28040
Teva Investigational Site 3146
Madrid, Spain, 28046
Teva Investigational Site 3137
Murcia, Spain, 30120
Teva Investigational Site 3138
Pontevedra, Spain, 36001
Teva Investigational Site 3136
Salt, Spain, 17190
Teva Investigational Site 3139
Santiago de Compostela, Spain, 15706
Teva Investigational Site 3143
Valencia, Spain, 46010
Sweden
Teva Investigational Site 4204
Stockholm, Sweden, 14186
Teva Investigational Site 4205
Stockholm, Sweden, 17176
Teva Investigational Site 4206
Stockholm, Sweden, 18288
Ukraine
Teva Investigational Site 5803
Dnipropetrovsk, Ukraine, 49027
Teva Investigational Site 5802
Kyiv, Ukraine, 03110
Teva Investigational Site 5804
Kyiv, Ukraine, 03115
Teva Investigational Site 5800
Lviv, Ukraine, 79010
Teva Investigational Site 5801
Vinnytsya, Ukraine, 21005
United Kingdom
Teva Investigational Site 3425
Liverpool, United Kingdom, L9 7LJ
Teva Investigational Site 3424
London, United Kingdom, E1 2AT
Teva Investigational Site 3422
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Investigators
Principal Investigator: Giancarlo Comi, Prof., MD U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology

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 Posted: October 1, 2009    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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