A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

NCT01047319 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: MS-LAQ-302E2009-015815-42
• Study Type: interventional
• Target: 1,047
• Locations: 17 countries
• Sites: 137

Brief Summary

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 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 7.13 years

Secondary Outcomes (4)

• Participants With Potentially Clinically Significant Abnormal Vital Signs

  Baseline (Day 0 for extension), Day 1 up to 7.13 years

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

  Baseline (Day 0), Day 1 to 7.13 years

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

  Baseline (Day 0), Day 1 to 7.13 years

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

  Baseline (Day 0), Day 1 to 7.13 years

Study Arms (1)

Experimental: 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.

Experimental: Laquinimod

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 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-302E study.

You may not qualify if:

• Premature discontinuation from the MS-LAQ-302 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-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E 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 (144)

Teva Investigational Site 1267

Homewood, Alabama, 35209, United States

Location

Teva Investigational Site 1237

Phoenix, Arizona, 85013, United States

Location

Teva Investigational Site 1279

Phoenix, Arizona, 85018, United States

Location

Teva Investigational Site 1276

Tucson, Arizona, 85704, United States

Location

Teva Investigational Site 1272

Pasadena, California, 91105, United States

Location

Teva Investigational Site 1238

Sacramento, California, 95817, United States

Location

Teva Investigational Site 1280

Aurora, Colorado, 80045, United States

Location

Teva Investigational Site 1282

Sarasota, Florida, 34233, United States

Location

Teva Investigational Site 1275

Atlanta, Georgia, 30309, United States

Location

Teva Investigational Site 1250

Peoria, Illinois, 61603, United States

Location

Teva Investigational Site 1260

Indianapolis, Indiana, 46202, United States

Location

Teva Investigational Site 1263

Shreveport, Louisiana, 71103, United States

Location

Teva Investigational Site 1269

Baltimore, Maryland, 21201, United States

Location

Teva Investigational Site 1273

Albany, New York, 12205, United States

Location

Teva Investigational Site 1264

Amherst, New York, 14226, United States

Location

Teva Investigational Site 1261

Akron, Ohio, 44320, United States

Location

Teva Investigational Site 1245

Cleveland, Ohio, 44195-5244, United States

Location

Teva Investigational Site 1247

Columbus, Ohio, 43221, United States

Location

Teva Investigational Site 1244

Portland, Oregon, 97225, United States

Location

Teva Investigational Site 1281

Nashville, Tennessee, 37205, United States

Location

Teva Investigational Site 1270

Roanoke, Virginia, 24018, United States

Location

Teva Investigational Site 1253

Tacoma, Washington, 98405, United States

Location

Teva Investigational Site 5914

Pleven, 5800, Bulgaria

Location

Teva Investigational Site 5915

Pleven, 5800, Bulgaria

Location

Teva Investigational Site 5917

Plovdiv, 4000, Bulgaria

Location

Teva Investigational Site 4212

Rousse, 7000, Bulgaria

Location

Teva Investigational Site 5916

Shumen, 9700, Bulgaria

Location

Teva Investigational Site 5920

Sofia, 1000, Bulgaria

Location

Teva Investigational Site 5907

Sofia, 1113, Bulgaria

Location

Teva Investigational Site 5910

Sofia, 1113, Bulgaria

Location

Teva Investigational Site 5909

Sofia, 1309, Bulgaria

Location

Teva Investigational Site 5919

Sofia, 1407, Bulgaria

Location

Teva Investigational Site 5906

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5908

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5911

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5912

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 5918

Stara Zagora, 6000, Bulgaria

Location

Teva Investigational Site 5913

Varna, 9010, Bulgaria

Location

Teva Investigational Site 4211

Veliko Tarnovo, 5000, Bulgaria

Location

Teva Investigational Site 6003

Osijek, 31 000, Croatia

Location

Teva Investigational Site 6005

Varaždin, 42000, Croatia

Location

Teva Investigational Site 6001

Zagreb, 10000, Croatia

Location

Teva Investigational Site 6002

Zagreb, 10000, Croatia

Location

Teva Investigational Site 6006

Zagreb, 10000, Croatia

Location

Teva Investigational Site 5419

Olomouc, 779 00, Czechia

Location

Teva Investigational Site 5418

Prague, 128 08, Czechia

Location

Teva Investigational Site 5420

Praha 5- Motol, 150 06, Czechia

Location

Teva Investigational Site 5421

Teplice, 415 29, Czechia

Location

Teva Investigational Site 5508

Kohtla-Järve, 31025, Estonia

Location

Teva Investigational Site 5507

Tallinn, EE-10617, Estonia

Location

Teva Investigational Site 5509

Tartu, EE-51014, Estonia

Location

Teva Investigational Site 8102

Tbilisi, 0112, Georgia

Location

Teva Investigational Site 8104

Tbilisi, 0112, Georgia

Location

Teva Investigational Site 8103

Tbilisi, 0179, Georgia

Location

Teva Investigational Site 6703

Berlin, 10117, Germany

Location

Teva Investigational Site 6402

Berlin, 12203, Germany

Location

Teva Investigational Site 6400

Ulm, 89081, Germany

Location

Teva Investigational Site 8041

Jerusalem, 9112001, Israel

Location

Teva Investigational Site 8040

Ramat Gan, 5262160, Israel

Location

Teva Investigational Site 3056

Bologna, 40139, Italy

Location

Teva Investigational Site 3053

Cefalù, 90015, Italy

Location

Teva Investigational Site 3054

Chieti, 66100, Italy

Location

Teva Investigational Site 3061

Empoli, 50053, Italy

Location

Teva Investigational Site 3049

Florence, 50139, Italy

Location

Teva Investigational Site 3055

Napoli, 80131, Italy

Location

Teva Investigational Site 3048

Rome, 00133, Italy

Location

Teva Investigational Site 3052

Rome, 00149, Italy

Location

Teva Investigational Site 3050

Rome, 00168, Italy

Location

Teva Investigational Site 5708

Kaunas, 50009, Lithuania

Location

Teva Investigational Site 5707

Šiauliai, 76231, Lithuania

Location

Teva Investigational Site 6500

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 6501

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 6502

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 5337

Bialystok, 15-402, Poland

Location

Teva Investigational Site 5329

Gdansk, 80-803, Poland

Location

Teva Investigational Site 5338

Gdansk, 80-952, Poland

Location

Teva Investigational Site 4213

Gmina Końskie, 26-200, Poland

Location

Teva Investigational Site 6602

Gorzów Wielkopolski, 66-400, Poland

Location

Teva Investigational Site 5333

Grodzisk Mazowiecki, 05-825, Poland

Location

Teva Investigational Site 5334

Katowice, 40-650, Poland

Location

Teva Investigational Site 5339

Katowice, 40-684, Poland

Location

Teva Investigational Site 6603

Kielce, 25-726, Poland

Location

Teva Investigational Site 5332

Kościerzyna, 83-400, Poland

Location

Teva Investigational Site 5345

Krakow, 31-826, Poland

Location

Teva Investigational Site 5328

Lodz, 90-153, Poland

Location

Teva Investigational Site 5330

Olsztyn, 10-560, Poland

Location

Teva Investigational Site 5331

Szczecin, 70-111, Poland

Location

Teva Investigational Site 5340

Warsaw, 00-909, Poland

Location

Teva Investigational Site 5341

Warsaw, 02-097, Poland

Location

Teva Investigational Site 5336

Warsaw, 02-957, Poland

Location

Teva Investigational Site 5335

Wroclaw, 50-556, Poland

Location

Teva Investigational Site 5235

Baloteşti, 077015, Romania

Location

Teva Investigational Site 5218

Bucharest, 010825, Romania

Location

Teva Investigational Site 5214

Bucharest, 022328, Romania

Location

Teva Investigational Site 5213

Bucharest, 050098, Romania

Location

Teva Investigational Site 5215

Cluj-Napoca, 400012, Romania

Location

Teva Investigational Site 5217

Constanța, 900591, Romania

Location

Teva Investigational Site 8209

Craiova, 200515, Romania

Location

Teva Investigational Site 5216

Iași, 700661, Romania

Location

Teva Investigational Site 5219

Sibiu, 550245, Romania

Location

Teva Investigational Site 5043

Barnaul, 656024, Russia

Location

Teva Investigational Site 5033

Moscow, 117152, Russia

Location

Teva Investigational Site 5041

Moscow, 125367, Russia

Location

Teva Investigational Site 5032

Moscow, 127015, Russia

Location

Teva Investigational Site 5038

Novosibirsk, 630087, Russia

Location

Teva Investigational Site 5042

Novosibirsk, 630117, Russia

Location

Teva Investigational Site 5036

Saint Petersburg, 194291, Russia

Location

Teva Investigational Site 5035

Saint Petersburg, 197022, Russia

Location

Teva Investigational Site 5034

Saint Petersburg, 197376, Russia

Location

Teva Investigational Site 5037

Samara, 443095, Russia

Location

Teva Investigational Site 5044

Ufa, 450007, Russia

Location

Teva Investigational Site 6200

Bratislava, 813 69, Slovakia

Location

Teva Investigational Site 6201

Bratislava, 826 06, Slovakia

Location

Teva Investigational Site 6202

Nitra, 949 01, Slovakia

Location

Teva Investigational Site 6203

Žilina, 010 01, Slovakia

Location

Teva Investigational Site 9007

Bloemfontein, 9301, South Africa

Location

Teva Investigational Site 9001

Cape Town, 7925, South Africa

Location

Teva Investigational Site 9004

Johannesburg, 2157, South Africa

Location

Teva Investigational Site 9003

Parktown- Johannesburg, 2193, South Africa

Location

Teva Investigational Site 9008

Pietermaritzburg, 3201, South Africa

Location

Teva Investigational Site 9005

Pretoria, 0041, South Africa

Location

Teva Investigational Site 9006

Rosebank, 2196, South Africa

Location

Teva Investigational Site 3147

Barcelona, 08035, Spain

Location

Teva Investigational Site 3154

Figueres-Girona, 17600, Spain

Location

Teva Investigational Site 3149

L'Hospitalet de Llobregat, 08907, Spain

Location

Teva Investigational Site 3152

Madrid, 28041, Spain

Location

Teva Investigational Site 3151

Málaga, 29010, Spain

Location

Teva Investigational Site 3148

Seville, 41009, Spain

Location

Teva Investigational Site 3153

Tortosa-Tarragona, 43500, Spain

Location

Teva Investigational Site 6503

Chernihiv, 14029, Ukraine

Location

Teva Investigational Site 5823

Chernivtsi, 58018, Ukraine

Location

Teva Investigational Site 5811

Dnipropetrovsk, 49027, Ukraine

Location

Teva Investigational Site 5812

Donetsk, 83003, Ukraine

Location

Teva Investigational Site 5814

Ivano-Frankivsk, 76008, Ukraine

Location

Teva Investigational Site 5817

Kharkiv, 61018, Ukraine

Location

Teva Investigational Site 5818

Kharkiv, 61068, Ukraine

Location

Teva Investigational Site 5815

Kharkiv, 61103, Ukraine

Location

Teva Investigational Site 5822

Kyiv, 03110, Ukraine

Location

Teva Investigational Site 5809

Lviv, 79010, Ukraine

Location

Teva Investigational Site 5820

Odesa, 65025, Ukraine

Location

Teva Investigational Site 5821

Poltava, 36024, Ukraine

Location

Teva Investigational Site 5810

Vinnytsia, 21005, Ukraine

Location

Teva Investigational Site 5819

Zaporizhzhya, 69035, Ukraine

Location

Teva Investigational Site 5816

Zaporizhzhya, 69600, Ukraine

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

• Prof. Timothy Vollmer, MD

  University of Colorado, Denver

  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: January 8, 2010
• First Posted: January 12, 2010
• Study Start: May 27, 2010
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: December 9, 2021
• Results First Posted: January 9, 2019

Record last verified: 2021-12

Locations

ES (3); US (22); CZ (4); RO (9); DE (3); SL (4); IT (9); ZA (7); UA (15); RU (11); CR (5); PL (18); LI (2); BU (17); IL (2); NO (3); GE (3)