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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

NCT ID: NCT01047319

Last Updated: 2021-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1047 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-27

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing Multiple Sclerosis

Keywords

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Laquinimod

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

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

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

Interventions

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Laquinimod

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Premature discontinuation from the MS-LAQ-302 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-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.
4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Timothy Vollmer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Teva Investigational Site 1267

Homewood, Alabama, United States

Site Status

Teva Investigational Site 1237

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 1279

Phoenix, Arizona, United States

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Teva Investigational Site 1276

Tucson, Arizona, United States

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Teva Investigational Site 1272

Pasadena, California, United States

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Teva Investigational Site 1238

Sacramento, California, United States

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Teva Investigational Site 1280

Aurora, Colorado, United States

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Teva Investigational Site 1282

Sarasota, Florida, United States

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Teva Investigational Site 1275

Atlanta, Georgia, United States

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Teva Investigational Site 1250

Peoria, Illinois, United States

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Teva Investigational Site 1260

Indianapolis, Indiana, United States

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Teva Investigational Site 1263

Shreveport, Louisiana, United States

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Teva Investigational Site 1269

Baltimore, Maryland, United States

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Teva Investigational Site 1273

Albany, New York, United States

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Teva Investigational Site 1264

Amherst, New York, United States

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Teva Investigational Site 1261

Akron, Ohio, United States

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Teva Investigational Site 1245

Cleveland, Ohio, United States

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Teva Investigational Site 1247

Columbus, Ohio, United States

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Teva Investigational Site 1244

Portland, Oregon, United States

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Teva Investigational Site 1281

Nashville, Tennessee, United States

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Teva Investigational Site 1270

Roanoke, Virginia, United States

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Teva Investigational Site 1253

Tacoma, Washington, United States

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Teva Investigational Site 5914

Pleven, , Bulgaria

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Teva Investigational Site 5915

Pleven, , Bulgaria

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Teva Investigational Site 5917

Plovdiv, , Bulgaria

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Teva Investigational Site 4212

Rousse, , Bulgaria

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Teva Investigational Site 5916

Shumen, , Bulgaria

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Teva Investigational Site 5920

Sofia, , Bulgaria

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Teva Investigational Site 5907

Sofia, , Bulgaria

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Teva Investigational Site 5910

Sofia, , Bulgaria

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Teva Investigational Site 5909

Sofia, , Bulgaria

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Teva Investigational Site 5919

Sofia, , Bulgaria

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Teva Investigational Site 5906

Sofia, , Bulgaria

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Teva Investigational Site 5908

Sofia, , Bulgaria

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Teva Investigational Site 5911

Sofia, , Bulgaria

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Teva Investigational Site 5912

Sofia, , Bulgaria

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Teva Investigational Site 5918

Stara Zagora, , Bulgaria

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Teva Investigational Site 5913

Varna, , Bulgaria

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Teva Investigational Site 4211

Veliko Tarnovo, , Bulgaria

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Teva Investigational Site 6003

Osijek, , Croatia

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Teva Investigational Site 6005

Varaždin, , Croatia

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Teva Investigational Site 6001

Zagreb, , Croatia

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Teva Investigational Site 6002

Zagreb, , Croatia

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Teva Investigational Site 6006

Zagreb, , Croatia

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Teva Investigational Site 5419

Olomouc, , Czechia

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Teva Investigational Site 5418

Prague, , Czechia

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Teva Investigational Site 5420

Praha 5- Motol, , Czechia

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Teva Investigational Site 5421

Teplice, , Czechia

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Teva Investigational Site 5508

Kohtla-Järve, , Estonia

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Teva Investigational Site 5507

Tallinn, , Estonia

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Teva Investigational Site 5509

Tartu, , Estonia

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Teva Investigational Site 8102

Tbilisi, , Georgia

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Teva Investigational Site 8104

Tbilisi, , Georgia

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Teva Investigational Site 8103

Tbilisi, , Georgia

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Teva Investigational Site 6703

Berlin, , Germany

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Teva Investigational Site 6402

Berlin, , Germany

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Teva Investigational Site 6400

Ulm, , Germany

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Teva Investigational Site 8041

Jerusalem, , Israel

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Teva Investigational Site 8040

Ramat Gan, , Israel

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Teva Investigational Site 3056

Bologna, , Italy

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Teva Investigational Site 3053

Cefalù, , Italy

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Teva Investigational Site 3054

Chieti, , Italy

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Teva Investigational Site 3061

Empoli, , Italy

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Teva Investigational Site 3049

Florence, , Italy

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Teva Investigational Site 3055

Napoli, , Italy

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Teva Investigational Site 3048

Rome, , Italy

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Teva Investigational Site 3052

Rome, , Italy

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Teva Investigational Site 3050

Rome, , Italy

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Teva Investigational Site 5708

Kaunas, , Lithuania

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Teva Investigational Site 5707

Šiauliai, , Lithuania

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Teva Investigational Site 6500

Skopje, , North Macedonia

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Teva Investigational Site 6501

Skopje, , North Macedonia

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Teva Investigational Site 6502

Skopje, , North Macedonia

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Teva Investigational Site 5337

Bialystok, , Poland

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Teva Investigational Site 5329

Gdansk, , Poland

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Teva Investigational Site 5338

Gdansk, , Poland

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Teva Investigational Site 4213

Gmina Końskie, , Poland

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Teva Investigational Site 6602

Gorzów Wielkopolski, , Poland

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Teva Investigational Site 5333

Grodzisk Mazowiecki, , Poland

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Teva Investigational Site 5334

Katowice, , Poland

Site Status

Teva Investigational Site 5339

Katowice, , Poland

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Teva Investigational Site 6603

Kielce, , Poland

Site Status

Teva Investigational Site 5332

Kościerzyna, , Poland

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Teva Investigational Site 5345

Krakow, , Poland

Site Status

Teva Investigational Site 5328

Lodz, , Poland

Site Status

Teva Investigational Site 5330

Olsztyn, , Poland

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Teva Investigational Site 5331

Szczecin, , Poland

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Teva Investigational Site 5340

Warsaw, , Poland

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Teva Investigational Site 5341

Warsaw, , Poland

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Teva Investigational Site 5336

Warsaw, , Poland

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Teva Investigational Site 5335

Wroclaw, , Poland

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Teva Investigational Site 5235

Baloteşti, , Romania

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Teva Investigational Site 5218

Bucharest, , Romania

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Teva Investigational Site 5214

Bucharest, , Romania

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Teva Investigational Site 5213

Bucharest, , Romania

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Teva Investigational Site 5215

Cluj-Napoca, , Romania

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Teva Investigational Site 5217

Constanța, , Romania

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Teva Investigational Site 8209

Craiova, , Romania

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Teva Investigational Site 5216

Iași, , Romania

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Teva Investigational Site 5219

Sibiu, , Romania

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Teva Investigational Site 5043

Barnaul, , Russia

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Teva Investigational Site 5033

Moscow, , Russia

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Teva Investigational Site 5041

Moscow, , Russia

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Teva Investigational Site 5032

Moscow, , Russia

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Teva Investigational Site 5038

Novosibirsk, , Russia

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Teva Investigational Site 5042

Novosibirsk, , Russia

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Teva Investigational Site 5036

Saint Petersburg, , Russia

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Teva Investigational Site 5035

Saint Petersburg, , Russia

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Teva Investigational Site 5034

Saint Petersburg, , Russia

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Teva Investigational Site 5037

Samara, , Russia

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Teva Investigational Site 5044

Ufa, , Russia

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Teva Investigational Site 6200

Bratislava, , Slovakia

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Teva Investigational Site 6201

Bratislava, , Slovakia

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Teva Investigational Site 6202

Nitra, , Slovakia

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Teva Investigational Site 6203

Žilina, , Slovakia

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Teva Investigational Site 9007

Bloemfontein, , South Africa

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Teva Investigational Site 9001

Cape Town, , South Africa

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Teva Investigational Site 9004

Johannesburg, , South Africa

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Teva Investigational Site 9003

Parktown- Johannesburg, , South Africa

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Teva Investigational Site 9008

Pietermaritzburg, , South Africa

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Teva Investigational Site 9005

Pretoria, , South Africa

Site Status

Teva Investigational Site 9006

Rosebank, , South Africa

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Teva Investigational Site 3147

Barcelona, , Spain

Site Status

Teva Investigational Site 3154

Figueres-Girona, , Spain

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Teva Investigational Site 3149

L'Hospitalet de Llobregat, , Spain

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Teva Investigational Site 3152

Madrid, , Spain

Site Status

Teva Investigational Site 3151

Málaga, , Spain

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Teva Investigational Site 3148

Seville, , Spain

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Teva Investigational Site 3153

Tortosa-Tarragona, , Spain

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Teva Investigational Site 6503

Chernihiv, , Ukraine

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Teva Investigational Site 5823

Chernivtsi, , Ukraine

Site Status

Teva Investigational Site 5811

Dnipropetrovsk, , Ukraine

Site Status

Teva Investigational Site 5812

Donetsk, , Ukraine

Site Status

Teva Investigational Site 5814

Ivano-Frankivsk, , Ukraine

Site Status

Teva Investigational Site 5817

Kharkiv, , Ukraine

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Teva Investigational Site 5818

Kharkiv, , Ukraine

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Teva Investigational Site 5815

Kharkiv, , Ukraine

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Teva Investigational Site 5822

Kyiv, , Ukraine

Site Status

Teva Investigational Site 5809

Lviv, , Ukraine

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Teva Investigational Site 5820

Odesa, , Ukraine

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Teva Investigational Site 5821

Poltava, , Ukraine

Site Status

Teva Investigational Site 5810

Vinnytsia, , Ukraine

Site Status

Teva Investigational Site 5819

Zaporizhzhya, , Ukraine

Site Status

Teva Investigational Site 5816

Zaporizhzhya, , Ukraine

Site Status

Countries

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Puerto Rico United States Bulgaria Croatia Czechia Estonia Georgia Germany Israel Italy Lithuania North Macedonia Poland Romania Russia Slovakia South Africa Spain Ukraine

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2009-015815-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS-LAQ-302E

Identifier Type: -

Identifier Source: org_study_id