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

NCT00988052 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: MS-LAQ-301E2009-012989-30
• Study Type: interventional
• Target: 839
• Locations: 21 countries
• Sites: 120

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Participants With Treatment-Emergent Adverse Events (TEAEs)

  A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.

  Day 1 up to 7.64 years

Secondary Outcomes (4)

• Participants With Potentially Clinically Significant Abnormal Vital Signs

  Day 1 up to 7.64 years

• Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study

  Day 1 up to 7.64 years

• Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study

  Day 1 up to 7.64 years

• Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study

  Day 1 up to 7.64 years

Study Arms (1)

Laquinimod

EXPERIMENTAL

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

Drug: Laquinimod

Interventions

Laquinimod DRUG

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

Laquinimod

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
• 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..
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
• Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.

You may not qualify if:

• Premature discontinuation from the MS-LAQ-301 study, for any reason.
• Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding.
• 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.
• Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (135)

Teva Investigational Site 1076

Phoenix, Arizona, 85004, United States

Location

Teva Investigational Site 1090

Centennial, Colorado, 80112, United States

Location

Teva Investigational Site 1088

Fort Collins, Colorado, 80528, United States

Location

Teva Investigational Site 1102

Northbrook, Illinois, 60062, United States

Location

Teva Investigational Site 1081

Fort Wayne, Indiana, 46845, United States

Location

Teva Investigational Site 1083

Des Moines, Iowa, 50314, United States

Location

Teva Investigational Site 1086

Kansas City, Kansas, 66103, United States

Location

Teva Investigational Site 1101

Lexington, Kentucky, 40513, United States

Location

Teva Investigational Site 1096

Farmington Hills, Michigan, 48334, United States

Location

Teva Investigational Site 1093

Minneapolis, Minnesota, 55414, United States

Location

Teva Investigational Site 1098

St Louis, Missouri, 63104, United States

Location

Teva Investigational Site 1082

New York, New York, 10016, United States

Location

Teva Investigational Site 1073

Winston-Salem, North Carolina, 27157, United States

Location

Teva Investigational Site 1097

Fargo, North Dakota, 58103, United States

Location

Teva Investigational Site 1084

Dayton, Ohio, 45417, United States

Location

Teva Investigational Site 1092

Oklahoma City, Oklahoma, 73120, United States

Location

Teva Investigational Site 1100

Hershey, Pennsylvania, 17033-0850, United States

Location

Teva Investigational Site 1075

Lubbock, Texas, 79410, United States

Location

Teva Investigational Site 1078

San Antonio, Texas, 78231, United States

Location

Teva Investigational Site 1085

Milwaukee, Wisconsin, 53215, United States

Location

Teva Investigational Site 3300

Klagenfurt, 9020, Austria

Location

Teva Investigational Site 3303

Linz, A-4021, Austria

Location

Teva Investigational Site 3302

Sankt Pölten, 3100, Austria

Location

Teva Investigational Site 5901

Pleven, 5800, Bulgaria

Location

Teva Investigational Site 5904

Sofia, 1113, Bulgaria

Location

Teva Investigational Site 5903

Sofia, 1309, Bulgaria

Location

Teva Investigational Site 5900

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5905

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5902

Varna, 9010, Bulgaria

Location

Teva Investigational Site 1132

Bedford, Nova Scotia, B4A 1A9, Canada

Location

Teva Investigational Site 1126

London, Ontario, N6A 5A5, Canada

Location

Teva Investigational Site 1128

Ottawa, Ontario, K2G 6E2, Canada

Location

Teva Investigational Site 1134

Toronto, Ontario, M4N 3M5, Canada

Location

Teva Investigational Site 1130

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Teva Investigational Site 1129

Montreal, Quebec, H1T 2M4, Canada

Location

Teva Investigational Site 1131

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Teva Investigational Site 5417

Olomouc, 779 00, Czechia

Location

Teva Investigational Site 5416

Ostrava - Poruba, 708 52, Czechia

Location

Teva Investigational Site 5504

Tallinn, EE-10617, Estonia

Location

Teva Investigational Site 5505

Tartu, EE-51014, Estonia

Location

Teva Investigational Site 3525

Besançon, 25030, France

Location

Teva Investigational Site 3527

Bron, 69677, France

Location

Teva Investigational Site 3526

Clermont-Ferrand, 63003, France

Location

Teva Investigational Site 3524

Lille, 59037, France

Location

Teva Investigational Site 3528

Marseille, 13385, France

Location

Teva Investigational Site 3529

Rennes, 35033, France

Location

Teva Investigational Site 8100

Tbilisi, 0112, Georgia

Location

Teva Investigational Site 8101

Tbilisi, 0179, Georgia

Location

Teva Investigational Site 3247

Bayreuth, 95445, Germany

Location

Teva Investigational Site 3241

Berlin, 10713, Germany

Location

Teva Investigational Site 3238

Berlin, 13347, Germany

Location

Teva Investigational Site 3248

Bochum, 44791, Germany

Location

Teva Investigational Site 3245

Dresden, 01307, Germany

Location

Teva Investigational Site 3237

Emden, 26721, Germany

Location

Teva Investigational Site 3242

Erbach im Odenwald, 64711, Germany

Location

Teva Investigational Site 3240

Erfurt, 99089, Germany

Location

Teva Investigational Site 3249

Freiburg im Breisgau, 79106, Germany

Location

Teva Investigational Site 3236

Hamburg, 20246, Germany

Location

Teva Investigational Site 3246

Hamburg, 22417, Germany

Location

Teva Investigational Site 3239

Hanover, 30171, Germany

Location

Teva Investigational Site 3243

Heidelberg, 69120, Germany

Location

Teva Investigational Site 3251

Münster, 48149, Germany

Location

Teva Investigational Site 3250

Trier, 54292, Germany

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Teva Investigational Site 3244

Ulm, 89081, Germany

Location

Teva Investigational Site 5115

Budapest, H-1145, Hungary

Location

Teva Investigational Site 5114

Debrecen, 4043, Hungary

Location

Teva Investigational Site 5116

Miskolc, 3526, Hungary

Location

Teva Investigational Site 5117

Veszprém, H-8200, Hungary

Location

Teva Investigational Site 8031

Haifa, 3436212, Israel

Location

Teva Investigational Site 8030

Jerusalem, 9112001, Israel

Location

Teva Investigational Site 8033

Ramat Gan, 5262160, Israel

Location

Teva Investigational Site 8032

Tel Aviv, 78278, Israel

Location

Teva Investigational Site 3044

Catania, 95124, Italy

Location

Teva Investigational Site 3045

Fidenza, 43036, Italy

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Teva Investigational Site 3042

Gallarate, 21013, Italy

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Teva Investigational Site 3046

Grosseto, 58100, Italy

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Teva Investigational Site 3038

Milan, 20132, Italy

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Teva Investigational Site 555

Milan, 20132, Italy

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Teva Investigational Site 3039

Milan, 20148, Italy

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Teva Investigational Site 3041

Palermo, 90146, Italy

Location

Teva Investigational Site 3040

Rome, 00133, Italy

Location

Teva Investigational Site 5704

Kaunas, 50009, Lithuania

Location

Teva Investigational Site 5705

Šiauliai, 76231, Lithuania

Location

Teva Investigational Site 3810

Nieuwegein, 3430 EM, Netherlands

Location

Teva Investigational Site 3809

Nijmegen, 6525 GC, Netherlands

Location

Teva Investigational Site 5322

Częstochowa, 42-280, Poland

Location

Teva Investigational Site 5319

Gmina Końskie, 26-200, Poland

Location

Teva Investigational Site 5320

Gorzów Wielkopolski, 66-400, Poland

Location

Teva Investigational Site 5316

Katowice, 40-752, Poland

Location

Teva Investigational Site 5318

Kielce, 25-726, Poland

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Teva Investigational Site 5317

Krakow, 31-826, Poland

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Teva Investigational Site 5315

Lodz, 90-153, Poland

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Teva Investigational Site 5325

Warsaw, 04-749, Poland

Location

Teva Investigational Site 5208

Bucharest, 011461, Romania

Location

Teva Investigational Site 5210

Cluj-Napoca, 400437, Romania

Location

Teva Investigational Site 5212

Constanța, 900123, Romania

Location

Teva Investigational Site 5211

Târgu Mureş, 540136, Romania

Location

Teva Investigational Site 5209

Timișoara, 300736, Romania

Location

Teva Investigational Site 5021

Moscow, 127015, Russia

Location

Teva Investigational Site 5028

Nizhny Novgorod, 603126, Russia

Location

Teva Investigational Site 5027

Novosibirsk, 630087, Russia

Location

Teva Investigational Site 5030

Perm, 614990, Russia

Location

Teva Investigational Site 5026

Saint Petersburg, 191186, Russia

Location

Teva Investigational Site 5025

Saint Petersburg, 194044, Russia

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Teva Investigational Site 5024

Saint Petersburg, 194354, Russia

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Teva Investigational Site 5022

Saint Petersburg, 197022, Russia

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Teva Investigational Site 5023

Saint Petersburg, 197376, Russia

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Teva Investigational Site 5029

Yekaterinburg, 620102, Russia

Location

Teva Investigational Site 6100

Belgrade, 11000, Serbia

Location

Teva Investigational Site 6102

Niš, 18 000, Serbia

Location

Teva Investigational Site 3132

Barcelona, 08035, Spain

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Teva Investigational Site 3134

Barcelona, 08036, Spain

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Teva Investigational Site 3144

Barcelona, 08041, Spain

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Teva Investigational Site 3140

Beade-Pontevedra, 36312, Spain

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Teva Investigational Site 3142

Getafe, 28905, Spain

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Teva Investigational Site 3135

Lleida, 25198, Spain

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Teva Investigational Site 3133

Madrid, 28040, Spain

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Teva Investigational Site 3146

Madrid, 28046, Spain

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Teva Investigational Site 3137

Murcia, 30120, Spain

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Teva Investigational Site 3138

Pontevedra, 36001, Spain

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Teva Investigational Site 3136

Salt, 17190, Spain

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Teva Investigational Site 3139

Santiago de Compostela, 15706, Spain

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Teva Investigational Site 3143

Valencia, 46010, Spain

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Teva Investigational Site 4204

Stockholm, 14186, Sweden

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Teva Investigational Site 4205

Stockholm, 17176, Sweden

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Teva Investigational Site 4206

Stockholm, 18288, Sweden

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Teva Investigational Site 8201

Izmir, 35340, Turkey (Türkiye)

Location

Teva Investigational Site 5803

Dnipropetrovsk, 49027, Ukraine

Location

Teva Investigational Site 5802

Kyiv, 03110, Ukraine

Location

Teva Investigational Site 5804

Kyiv, 03115, Ukraine

Location

Teva Investigational Site 5800

Lviv, 79010, Ukraine

Location

Teva Investigational Site 5801

Vinnytsia, 21005, Ukraine

Location

Teva Investigational Site 3425

Liverpool, L9 7LJ, United Kingdom

Location

Teva Investigational Site 3424

London, E1 2AT, United Kingdom

Location

Teva Investigational Site 3422

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Interventions

laquinimod

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Pharmaceutical Industries, Ltd

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Giancarlo Comi, Prof., MD

  U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: October 1, 2009
• Study Start: November 10, 2009
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 9, 2021
• Results First Posted: January 8, 2019

Record last verified: 2021-12

Locations

CA (7); NL (2); PL (8); GE (2); SE (3); RU (10); ES (2); IT (9); TU (1); UA (5); DE (16); GB (3); HU (4); US (20); CZ (2); AU (3); BU (6); LI (2); RO (5); FR (6); IL (4)