Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)
NCT ID: NCT00509145
Last Updated: 2021-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1106 participants
INTERVENTIONAL
2007-11-13
2010-11-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Laquinimod
Laquinimod 0.6 mg, oral
Laquinimod
Laquinimod 0.6 mg capsule, oral, once daily
Placebo
Matching placebo
Placebo
oral, once daily, capsule
Interventions
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Laquinimod
Laquinimod 0.6 mg capsule, oral, once daily
Placebo
oral, once daily, capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5.
3. Subjects must be in a stable neurological condition and free of corticosteroid treatment \[intravenous (iv), intramuscular (im) and/or per os (po)\] 30 days prior to screening (month -1).
4. Subjects must have had experienced one of the following:
* At least one documented relapse in the 12 months prior to screening
* At least two documented relapses in the 24 months prior to screening
* One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
5. Subjects must be between 18 and 55 years of age, inclusive.
6. Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening.
7. Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide).
8. Subjects must be able to sign and date a written informed consent prior to entering the study
9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Exclusion Criteria
2. An onset of relapse, unstable neurological condition or any treatment with corticosteroids \[intravenous (iv), intramuscular (im) and/or per os (po)\] or ACTH between month -1 (screening) and 0 (baseline).
3. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
4. Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
5. Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod.
6. Previous treatment with glatiramer acetate (Copaxone®) Interferon-β (either 1a or 1b) or IVIG within 2 months prior to screening visit.
7. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
8. Previous total body irradiation or total lymphoid irradiation.
9. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
10. A known history of tuberculosis.
11. Acute infection two weeks prior to baseline visit.
12. Major trauma or surgery two weeks prior to baseline
13. A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
14. A carrier state of factor V Leiden mutation (either homo- or heterozygous) as disclosed at screening.
15. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
16. Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine) see detailed list in Appendix 5
17. Use of amiodarone within 2 years prior to screening visit.
18. Pregnancy or breastfeeding.
19. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:
* A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
* A gastrointestinal disorder that may affect the absorption of study medication.
* Renal or metabolic diseases.
* Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
* A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin
* A QTC interval (obtained from either 2 ECG recordings at screening or from the mean value calculated from 3 measurements at baseline visit) which is \>450msec.
* A family history of Long- QT syndrome.
* A history of drug and/or alcohol abuse.
* Major psychiatric disorder.
20. A known history of sensitivity to Gd.
21. Inability to successfully undergo MRI scanning.
22. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
1. Subjects who suffer from any form of progressive MS.
2. Any condition which the investigator feels may interfere with participation in the study.
3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
5. Previous treatment with immunomodulators within two months prior to screening
6. Pregnancy or breastfeeding.
18 Years
55 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Giancarlo Comi
Role: PRINCIPAL_INVESTIGATOR
U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Locations
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Teva Investigational Site 1076
Phoenix, Arizona, United States
Teva Investigational Site 1090
Centennial, Colorado, United States
Teva Investigational Site 1088
Fort Collins, Colorado, United States
Teva Investigational Site 1094
New Haven, Connecticut, United States
Teva Investigational Site 1102
Northbrook, Illinois, United States
Teva Investigational Site 1081
Fort Wayne, Indiana, United States
Teva Investigational Site 1083
Des Moines, Iowa, United States
Teva Investigational Site 1086
Kansas City, Kansas, United States
Teva Investigational Site 1101
Lexington, Kentucky, United States
Teva Investigational Site 1096
Farmington Hills, Michigan, United States
Teva Investigational Site 1093
Minneapolis, Minnesota, United States
Teva Investigational Site 1098
St Louis, Missouri, United States
Teva Investigational Site 1082
New York, New York, United States
Teva Investigational Site 1079
Rochester, New York, United States
Teva Investigational Site 1073
Winston-Salem, North Carolina, United States
Teva Investigational Site 1097
Fargo, North Dakota, United States
Teva Investigational Site 1084
Dayton, Ohio, United States
Teva Investigational Site 1092
Oklahoma City, Oklahoma, United States
Teva Investigational Site 1100
Hershey, Pennsylvania, United States
Teva Investigational Site 1087
Philadelphia, Pennsylvania, United States
Teva Investigational Site 1075
Lubbock, Texas, United States
Teva Investigational Site 1078
San Antonio, Texas, United States
Teva Investigational Site 1085
Milwaukee, Wisconsin, United States
Teva Investigational Site 3300
Klagenfurt, , Austria
Teva Investigational Site 3303
Linz, , Austria
Teva Investigational Site 3302
Sankt Pölten, , Austria
Teva Investigational Site 3301
Villach, , Austria
Teva Investigational Site 5901
Pleven, , Bulgaria
Teva Investigational Site 5904
Sofia, , Bulgaria
Teva Investigational Site 5903
Sofia, , Bulgaria
Teva Investigational Site 5900
Sofia, , Bulgaria
Teva Investigational Site 5905
Sofia, , Bulgaria
Teva Investigational Site 5902
Varna, , Bulgaria
Teva Investigational Site 1132
Halifax, Nova Scotia, Canada
Teva Investigational Site 1126
London, Ontario, Canada
Teva Investigational Site 1128
Ottawa, Ontario, Canada
Teva Investigational Site 1134
Toronto, Ontario, Canada
Teva Investigational Site 1130
Greenfield Park, Quebec, Canada
Teva Investigational Site 1129
Montreal, Quebec, Canada
Teva Investigational Site 1131
Sherbrooke, Quebec, Canada
Teva Investigational Site 5417
Olomouc, , Czechia
Teva Investigational Site 5416
Ostrava - Poruba, , Czechia
Teva Investigational Site 5504
Tallinn, , Estonia
Teva Investigational Site 5505
Tartu, , Estonia
Teva Investigational Site 3525
Besançon, , France
Teva Investigational Site 3527
Bron, , France
Teva Investigational Site 3526
Clermont-Ferrand, , France
Teva Investigational Site 3524
Lille, , France
Teva Investigational Site 3528
Marseille, , France
Teva Investigational Site 3529
Rennes, , France
Teva Investigational Site 8100
Tbilisi, , Georgia
Teva Investigational Site 8101
Tbilisi, , Georgia
Teva Investigational Site 3247
Bayreuth, , Germany
Teva Investigational Site 3241
Berlin, , Germany
Teva Investigational Site 3238
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 im Odenwald, , Germany
Teva Investigational Site 3240
Erfurt, , Germany
Teva Investigational Site 3249
Freiburg im Breisgau, , Germany
Teva Investigational Site 3236
Hamburg, , Germany
Teva Investigational Site 3246
Hamburg, , Germany
Teva Investigational Site 3239
Hanover, , Germany
Teva Investigational Site 3243
Heidelberg, , Germany
Teva Investigational Site 3251
Münster, , Germany
Teva Investigational Site 3250
Trier, , Germany
Teva Investigational Site 3244
Ulm, , Germany
Teva Investigational Site 5115
Budapest, , Hungary
Teva Investigational Site 5114
Debrecen, , Hungary
Teva Investigational Site 5116
Miskolc, , Hungary
Teva Investigational Site 5117
Veszprém, , Hungary
Teva Investigational Site 8034
Haifa, , Israel
Teva Investigational Site 8031
Haifa, , Israel
Teva Investigational Site 8030
Jerusalem, , Israel
Teva Investigational Site 8033
Ramat Gan, , Israel
Teva Investigational Site 8032
Tel Aviv, , Israel
Teva Investigational Site 3044
Catania, , Italy
Teva Investigational Site 3045
Fidenza, , Italy
Teva Investigational Site 3042
Gallarate, , Italy
Teva Investigational Site 3046
Grosseto, , Italy
Teva Investigational Site 3047
Milan, , Italy
Teva Investigational Site 3038
Milan, , Italy
Teva Investigational Site 555
Milan, , Italy
Teva Investigational Site 3039
Milan, , Italy
Teva Investigational Site 3041
Palermo, , Italy
Teva Investigational Site 3040
Rome, , Italy
Teva Investigational Site 5604
Riga, , Latvia
Teva Investigational Site 5704
Kaunas, , Lithuania
Teva Investigational Site 5705
Šiauliai, , Lithuania
Teva Investigational Site 3809
Groesbeek, , Netherlands
Teva Investigational Site 3810
Nieuwegein, , Netherlands
Teva Investigational Site 3811
Tilburg, , Netherlands
Teva Investigational Site 5322
Częstochowa, , Poland
Teva Investigational Site 5319
Gmina Końskie, , Poland
Teva Investigational Site 5320
Gorzów Wielkopolski, , Poland
Teva Investigational Site 5316
Katowice, , Poland
Teva Investigational Site 5318
Kielce, , Poland
Teva Investigational Site 5317
Krakow, , Poland
Teva Investigational Site 5315
Lodz, , Poland
Teva Investigational Site 5325
Warsaw, , Poland
Teva Investigational Site 5208
Bucharest, , Romania
Teva Investigational Site 5210
Cluj-Napoca, , Romania
Teva Investigational Site 5212
Constanța, , Romania
Teva Investigational Site 5211
Târgu Mureş, , Romania
Teva Investigational Site 5209
Timișoara, , Romania
Teva Investigational Site 5031
Kemerovo, , Russia
Teva Investigational Site 5021
Moscow, , Russia
Teva Investigational Site 5028
Nizhny Novgorod, , Russia
Teva Investigational Site 5027
Novosibirsk, , Russia
Teva Investigational Site 5030
Perm, , Russia
Teva Investigational Site 5026
Saint Petersburg, , Russia
Teva Investigational Site 5025
Saint Petersburg, , Russia
Teva Investigational Site 5024
Saint Petersburg, , Russia
Teva Investigational Site 5022
Saint Petersburg, , Russia
Teva Investigational Site 5023
Saint Petersburg, , Russia
Teva Investigational Site 5029
Yekaterinburg, , Russia
Teva Investigational Site 6100
Belgrade, , Serbia
Teva Investigational Site 6102
Niš, , Serbia
Teva Investigational Site 3132
Barcelona, , Spain
Teva Investigational Site 3134
Barcelona, , Spain
Teva Investigational Site 3144
Barcelona, , Spain
Teva Investigational Site 3140
Beade-Vigo, , Spain
Teva Investigational Site 3142
Getafe, , Spain
Teva Investigational Site 3136
Girona, , Spain
Teva Investigational Site 3135
Lleida, , Spain
Teva Investigational Site 3133
Madrid, , Spain
Teva Investigational Site 3146
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 4204
Stockholm, , Sweden
Teva Investigational Site 4205
Stockholm, , Sweden
Teva Investigational Site 4206
Stockholm, , Sweden
Teva Investigational Site 8201
Izmir, , Turkey (Türkiye)
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
Vinnytsia, , Ukraine
Teva Investigational Site 3425
Liverpool, , United Kingdom
Teva Investigational Site 3424
London, , United Kingdom
Teva Investigational Site 3422
Sheffield, , United Kingdom
Countries
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References
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Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.
Filippi M, Rocca MA, Pagani E, De Stefano N, Jeffery D, Kappos L, Montalban X, Boyko AN, Comi G; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):851-8. doi: 10.1136/jnnp-2013-306132. Epub 2013 Sep 12.
Comi G, Jeffery D, Kappos L, Montalban X, Boyko A, Rocca MA, Filippi M; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 Mar 15;366(11):1000-9. doi: 10.1056/NEJMoa1104318.
Other Identifiers
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EUDRACT 2007-003226-19
Identifier Type: -
Identifier Source: secondary_id
MS-LAQ-301
Identifier Type: -
Identifier Source: org_study_id