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Relapsing Multiple SclerosisPhase 3NCT01047319

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

A Phase 3 study testing Laquinimod in people with Relapsing Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 144 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Laquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,047 participants
Where
144 sitesin 18 countries
Study dates
27 May 2010to 30 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

144 sites in 18 countries.

144 sites in 18 countries

United States22 sites

  • Teva Investigational Site 1261

    Akron, Ohio, 44320

  • Teva Investigational Site 1273

    Albany, New York, 12205

  • Teva Investigational Site 1264

    Amherst, New York, 14226

  • Teva Investigational Site 1275

    Atlanta, Georgia, 30309

  • Teva Investigational Site 1280

    Aurora, Colorado, 80045

  • Teva Investigational Site 1269

    Baltimore, Maryland, 21201

  • Teva Investigational Site 1245

    Cleveland, Ohio, 44195-5244

  • Teva Investigational Site 1247

    Columbus, Ohio, 43221

  • Teva Investigational Site 1267

    Homewood, Alabama, 35209

  • Teva Investigational Site 1260

    Indianapolis, Indiana, 46202

  • Teva Investigational Site 1281

    Nashville, Tennessee, 37205

  • Teva Investigational Site 1272

    Pasadena, California, 91105

  • Teva Investigational Site 1250

    Peoria, Illinois, 61603

  • Teva Investigational Site 1237

    Phoenix, Arizona, 85013

  • Teva Investigational Site 1279

    Phoenix, Arizona, 85018

  • Teva Investigational Site 1244

    Portland, Oregon, 97225

  • Teva Investigational Site 1270

    Roanoke, Virginia, 24018

  • Teva Investigational Site 1238

    Sacramento, California, 95817

  • Teva Investigational Site 1282

    Sarasota, Florida, 34233

  • Teva Investigational Site 1263

    Shreveport, Louisiana, 71103

  • Teva Investigational Site 1253

    Tacoma, Washington, 98405

  • Teva Investigational Site 1276

    Tucson, Arizona, 85704

Other trials in United States

Poland18 sites

  • Teva Investigational Site 5337

    Bialystok, 15-402

  • Teva Investigational Site 5329

    Gdansk, 80-803

  • Teva Investigational Site 5338

    Gdansk, 80-952

  • Teva Investigational Site 4213

    Gmina Końskie, 26-200

  • Teva Investigational Site 6602

    Gorzów Wielkopolski, 66-400

  • Teva Investigational Site 5333

    Grodzisk Mazowiecki, 05-825

  • Teva Investigational Site 5334

    Katowice, 40-650

  • Teva Investigational Site 5339

    Katowice, 40-684

  • Teva Investigational Site 6603

    Kielce, 25-726

  • Teva Investigational Site 5332

    Kościerzyna, 83-400

  • Teva Investigational Site 5345

    Krakow, 31-826

  • Teva Investigational Site 5328

    Lodz, 90-153

  • Teva Investigational Site 5330

    Olsztyn, 10-560

  • Teva Investigational Site 5331

    Szczecin, 70-111

  • Teva Investigational Site 5340

    Warsaw, 00-909

  • Teva Investigational Site 5341

    Warsaw, 02-097

  • Teva Investigational Site 5336

    Warsaw, 02-957

  • Teva Investigational Site 5335

    Wroclaw, 50-556

Other trials in Poland

Bulgaria17 sites

  • Teva Investigational Site 5914

    Pleven, 5800

  • Teva Investigational Site 5915

    Pleven, 5800

  • Teva Investigational Site 5917

    Plovdiv, 4000

  • Teva Investigational Site 4212

    Rousse, 7000

  • Teva Investigational Site 5916

    Shumen, 9700

  • Teva Investigational Site 5920

    Sofia, 1000

  • Teva Investigational Site 5907

    Sofia, 1113

  • Teva Investigational Site 5910

    Sofia, 1113

  • Teva Investigational Site 5909

    Sofia, 1309

  • Teva Investigational Site 5919

    Sofia, 1407

  • Teva Investigational Site 5906

    Sofia, 1606

  • Teva Investigational Site 5908

    Sofia, 1606

  • Teva Investigational Site 5911

    Sofia, 1606

  • Teva Investigational Site 5912

    Sofia, 1606

  • Teva Investigational Site 5918

    Stara Zagora, 6000

  • Teva Investigational Site 5913

    Varna, 9010

  • Teva Investigational Site 4211

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Ukraine15 sites

  • Teva Investigational Site 6503

    Chernihiv, 14029

  • Teva Investigational Site 5823

    Chernivtsi, 58018

  • Teva Investigational Site 5811

    Dnipropetrovsk, 49027

  • Teva Investigational Site 5812

    Donetsk, 83003

  • Teva Investigational Site 5814

    Ivano-Frankivsk, 76008

  • Teva Investigational Site 5817

    Kharkiv, 61018

  • Teva Investigational Site 5818

    Kharkiv, 61068

  • Teva Investigational Site 5815

    Kharkiv, 61103

  • Teva Investigational Site 5822

    Kyiv, 03110

  • Teva Investigational Site 5809

    Lviv, 79010

  • Teva Investigational Site 5820

    Odesa, 65025

  • Teva Investigational Site 5821

    Poltava, 36024

  • Teva Investigational Site 5810

    Vinnytsia, 21005

  • Teva Investigational Site 5819

    Zaporizhzhya, 69035

  • Teva Investigational Site 5816

    Zaporizhzhya, 69600

Other trials in Ukraine

Russia11 sites

  • Teva Investigational Site 5043

    Barnaul, 656024

  • Teva Investigational Site 5033

    Moscow, 117152

  • Teva Investigational Site 5041

    Moscow, 125367

  • Teva Investigational Site 5032

    Moscow, 127015

  • Teva Investigational Site 5038

    Novosibirsk, 630087

  • Teva Investigational Site 5042

    Novosibirsk, 630117

  • Teva Investigational Site 5036

    Saint Petersburg, 194291

  • Teva Investigational Site 5035

    Saint Petersburg, 197022

  • Teva Investigational Site 5034

    Saint Petersburg, 197376

  • Teva Investigational Site 5037

    Samara, 443095

  • Teva Investigational Site 5044

    Ufa, 450007

Other trials in Russia

Italy9 sites

  • Teva Investigational Site 3056

    Bologna, 40139

  • Teva Investigational Site 3053

    Cefalù, 90015

  • Teva Investigational Site 3054

    Chieti, 66100

  • Teva Investigational Site 3061

    Empoli, 50053

  • Teva Investigational Site 3049

    Florence, 50139

  • Teva Investigational Site 3055

    Naples, 80131

  • Teva Investigational Site 3048

    Rome, 00133

  • Teva Investigational Site 3052

    Rome, 00149

  • Teva Investigational Site 3050

    Rome, 00168

Other trials in Italy

Romania9 sites

  • Teva Investigational Site 5235

    Baloteşti, 077015

  • Teva Investigational Site 5218

    Bucharest, 010825

  • Teva Investigational Site 5214

    Bucharest, 022328

  • Teva Investigational Site 5213

    Bucharest, 050098

  • Teva Investigational Site 5215

    Cluj-Napoca, 400012

  • Teva Investigational Site 5217

    Constanța, 900591

  • Teva Investigational Site 8209

    Craiova, 200515

  • Teva Investigational Site 5216

    Iași, 700661

  • Teva Investigational Site 5219

    Sibiu, 550245

Other trials in Romania

South Africa7 sites

  • Teva Investigational Site 9007

    Bloemfontein, 9301

  • Teva Investigational Site 9001

    Cape Town, 7925

  • Teva Investigational Site 9004

    Johannesburg, 2157

  • Teva Investigational Site 9003

    Parktown- Johannesburg, 2193

  • Teva Investigational Site 9008

    Pietermaritzburg, 3201

  • Teva Investigational Site 9005

    Pretoria, 0041

  • Teva Investigational Site 9006

    Rosebank, 2196

Other trials in South Africa

Spain7 sites

  • Teva Investigational Site 3147

    Barcelona, 08035

  • Teva Investigational Site 3154

    Figueres-Girona, 17600

  • Teva Investigational Site 3149

    L'Hospitalet de Llobregat, 08907

  • Teva Investigational Site 3152

    Madrid, 28041

  • Teva Investigational Site 3151

    Málaga, 29010

  • Teva Investigational Site 3148

    Seville, 41009

  • Teva Investigational Site 3153

    Tortosa-Tarragona, 43500

Other trials in Spain

Croatia5 sites

  • Teva Investigational Site 6003

    Osijek, 31 000

  • Teva Investigational Site 6005

    Varaždin, 42000

  • Teva Investigational Site 6001

    Zagreb, 10000

  • Teva Investigational Site 6002

    Zagreb, 10000

  • Teva Investigational Site 6006

    Zagreb, 10000

Other trials in Croatia

Czechia4 sites

  • Teva Investigational Site 5419

    Olomouc, 779 00

  • Teva Investigational Site 5418

    Prague, 128 08

  • Teva Investigational Site 5420

    Praha 5- Motol, 150 06

  • Teva Investigational Site 5421

    Teplice, 415 29

Other trials in Czechia

Slovakia4 sites

  • Teva Investigational Site 6200

    Bratislava, 813 69

  • Teva Investigational Site 6201

    Bratislava, 826 06

  • Teva Investigational Site 6202

    Nitra, 949 01

  • Teva Investigational Site 6203

    Žilina, 010 01

Other trials in Slovakia

Estonia3 sites

  • Teva Investigational Site 5508

    Kohtla-Järve, 31025

  • Teva Investigational Site 5507

    Tallinn, EE-10617

  • Teva Investigational Site 5509

    Tartu, EE-51014

Other trials in Estonia

Georgia3 sites

  • Teva Investigational Site 8102

    Tbilisi, 0112

  • Teva Investigational Site 8104

    Tbilisi, 0112

  • Teva Investigational Site 8103

    Tbilisi, 0179

Other trials in Georgia

Germany3 sites

  • Teva Investigational Site 6703

    Berlin, 10117

  • Teva Investigational Site 6402

    Berlin, 12203

  • Teva Investigational Site 6400

    Ulm, 89081

Other trials in Germany

North Macedonia3 sites

  • Teva Investigational Site 6500

    Skopje, 1000

  • Teva Investigational Site 6501

    Skopje, 1000

  • Teva Investigational Site 6502

    Skopje, 1000

Other trials in North Macedonia

Israel2 sites

  • Teva Investigational Site 8041

    Jerusalem, 9112001

  • Teva Investigational Site 8040

    Ramat Gan, 5262160

Other trials in Israel

Lithuania2 sites

  • Teva Investigational Site 5708

    Kaunas, 50009

  • Teva Investigational Site 5707

    Šiauliai, 76231

Other trials in Lithuania

About this study

Official title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, 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

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.

Being tested
Laquinimod
Keywords
Relapsing Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaquinimodDrug

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

Study groups in NCT01047319
Study groupRoleWhat they receive
Experimental: LaquinimodExperimentalOne capsule containing 0.6 mg laquinimod to be administered orally once daily.
Receives: Drug: Laquinimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 up to 7.13 years

Secondary outcomes (4)

  1. Participants With Potentially Clinically Significant Abnormal Vital Signs

    Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:

    • Pulse rate: >=120 and increase >=30 beats/minute
    • Systolic blood pressure low: <=90 and decrease >=30 mmHg
    • Systolic blood pressure high: >=180 and increase >=30 mmHg
    • Diastolic blood pressure low: <=50 and decrease >=20 mmHg
    • Diastolic blood pressure high: >=100 and increase >=20 mmHg

    Note that the change is compared to baseline,

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

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

    Counts include two conditions:

    • a change from High / Non-PCS at baseline to Low PCS at any point during the study
    • a change from Low / Non-PCS at baseline to High PCS at any point during the study

    Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.

    ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium

    Measured: Baseline (Day 0), Day 1 to 7.13 years

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

    Counts include two conditions:

    • a change from High / Non-PCS at baseline to Low PCS at any point during the study
    • a change from Low / Non-PCS at baseline to High PCS at any point during the study

    Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.

    Measured: Baseline (Day 0), Day 1 to 7.13 years

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

    Shifts are presented as Baseline finding / Worse finding at anytime during the study.

    Categories for findings are:

    • normal
    • abnormal, not clinically significant (Not CS)
    • abnormal, clinically significant (CS)

    Measured: Baseline (Day 0), Day 1 to 7.13 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2010 (estimated)
  2. Study start27 May 2010
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Why it stopped: Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,047 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01047319
Sponsor's protocol ID
MS-LAQ-302E
Other IDs
2009-015815-42, 2009
Status last verified
Dec 2021
First submitted
8 Jan 2010
Last updated
9 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laquinimod in people with Relapsing Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 144 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Poland, Bulgaria, Ukraine, Russia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 up to 7.13 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01047319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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