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Relapsing Multiple SclerosisPhase 3NCT00988052

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

A Phase 3 study testing Laquinimod in people with Relapsing Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 135 sites in 23 countries.

Terminated

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
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
839 participants
Where
135 sitesin 23 countries
Study dates
10 Nov 2009to 1 Jul 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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

135 sites in 23 countries.

135 sites in 23 countries

United States20 sites

  • Teva Investigational Site 1090

    Centennial, Colorado, 80112

  • Teva Investigational Site 1084

    Dayton, Ohio, 45417

  • Teva Investigational Site 1083

    Des Moines, Iowa, 50314

  • Teva Investigational Site 1097

    Fargo, North Dakota, 58103

  • Teva Investigational Site 1096

    Farmington Hills, Michigan, 48334

  • Teva Investigational Site 1088

    Fort Collins, Colorado, 80528

  • Teva Investigational Site 1081

    Fort Wayne, Indiana, 46845

  • Teva Investigational Site 1100

    Hershey, Pennsylvania, 17033-0850

  • Teva Investigational Site 1086

    Kansas City, Kansas, 66103

  • Teva Investigational Site 1101

    Lexington, Kentucky, 40513

  • Teva Investigational Site 1075

    Lubbock, Texas, 79410

  • Teva Investigational Site 1085

    Milwaukee, Wisconsin, 53215

  • Teva Investigational Site 1093

    Minneapolis, Minnesota, 55414

  • Teva Investigational Site 1082

    New York, New York, 10016

  • Teva Investigational Site 1102

    Northbrook, Illinois, 60062

  • Teva Investigational Site 1092

    Oklahoma City, Oklahoma, 73120

  • Teva Investigational Site 1076

    Phoenix, Arizona, 85004

  • Teva Investigational Site 1078

    San Antonio, Texas, 78231

  • Teva Investigational Site 1098

    St Louis, Missouri, 63104

  • Teva Investigational Site 1073

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany16 sites

  • Teva Investigational Site 3247

    Bayreuth, 95445

  • Teva Investigational Site 3241

    Berlin, 10713

  • Teva Investigational Site 3238

    Berlin, 13347

  • Teva Investigational Site 3248

    Bochum, 44791

  • Teva Investigational Site 3245

    Dresden, 01307

  • Teva Investigational Site 3237

    Emden, 26721

  • Teva Investigational Site 3242

    Erbach im Odenwald, 64711

  • Teva Investigational Site 3240

    Erfurt, 99089

  • Teva Investigational Site 3249

    Freiburg im Breisgau, 79106

  • Teva Investigational Site 3236

    Hamburg, 20246

  • Teva Investigational Site 3246

    Hamburg, 22417

  • Teva Investigational Site 3239

    Hanover, 30171

  • Teva Investigational Site 3243

    Heidelberg, 69120

  • Teva Investigational Site 3251

    Münster, 48149

  • Teva Investigational Site 3250

    Trier, 54292

  • Teva Investigational Site 3244

    Ulm, 89081

Other trials in Germany

Spain13 sites

  • Teva Investigational Site 3132

    Barcelona, 08035

  • Teva Investigational Site 3134

    Barcelona, 08036

  • Teva Investigational Site 3144

    Barcelona, 08041

  • Teva Investigational Site 3140

    Beade-Pontevedra, 36312

  • Teva Investigational Site 3142

    Getafe, 28905

  • Teva Investigational Site 3135

    Lleida, 25198

  • Teva Investigational Site 3133

    Madrid, 28040

  • Teva Investigational Site 3146

    Madrid, 28046

  • Teva Investigational Site 3137

    Murcia, 30120

  • Teva Investigational Site 3138

    Pontevedra, 36001

  • Teva Investigational Site 3136

    Salt, 17190

  • Teva Investigational Site 3139

    Santiago de Compostela, 15706

  • Teva Investigational Site 3143

    Valencia, 46010

Other trials in Spain

Russia10 sites

  • Teva Investigational Site 5021

    Moscow, 127015

  • Teva Investigational Site 5028

    Nizhny Novgorod, 603126

  • Teva Investigational Site 5027

    Novosibirsk, 630087

  • Teva Investigational Site 5030

    Perm, 614990

  • Teva Investigational Site 5026

    Saint Petersburg, 191186

  • Teva Investigational Site 5025

    Saint Petersburg, 194044

  • Teva Investigational Site 5024

    Saint Petersburg, 194354

  • Teva Investigational Site 5022

    Saint Petersburg, 197022

  • Teva Investigational Site 5023

    Saint Petersburg, 197376

  • Teva Investigational Site 5029

    Yekaterinburg, 620102

Other trials in Russia

Italy9 sites

  • Teva Investigational Site 3044

    Catania, 95124

  • Teva Investigational Site 3045

    Fidenza, 43036

  • Teva Investigational Site 3042

    Gallarate, 21013

  • Teva Investigational Site 3046

    Grosseto, 58100

  • Teva Investigational Site 3038

    Milan, 20132

  • Teva Investigational Site 555

    Milan, 20132

  • Teva Investigational Site 3039

    Milan, 20148

  • Teva Investigational Site 3041

    Palermo, 90146

  • Teva Investigational Site 3040

    Rome, 00133

Other trials in Italy

Poland8 sites

  • Teva Investigational Site 5322

    Częstochowa, 42-280

  • Teva Investigational Site 5319

    Gmina Końskie, 26-200

  • Teva Investigational Site 5320

    Gorzów Wielkopolski, 66-400

  • Teva Investigational Site 5316

    Katowice, 40-752

  • Teva Investigational Site 5318

    Kielce, 25-726

  • Teva Investigational Site 5317

    Krakow, 31-826

  • Teva Investigational Site 5315

    Lodz, 90-153

  • Teva Investigational Site 5325

    Warsaw, 04-749

Other trials in Poland

Canada7 sites

  • Teva Investigational Site 1132

    Bedford, Nova Scotia, B4A 1A9

  • Teva Investigational Site 1130

    Greenfield Park, Quebec, J4V 2J2

  • Teva Investigational Site 1126

    London, Ontario, N6A 5A5

  • Teva Investigational Site 1129

    Montreal, Quebec, H1T 2M4

  • Teva Investigational Site 1128

    Ottawa, Ontario, K2G 6E2

  • Teva Investigational Site 1131

    Sherbrooke, Quebec, J1H 5N4

  • Teva Investigational Site 1134

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Bulgaria6 sites

  • Teva Investigational Site 5901

    Pleven, 5800

  • Teva Investigational Site 5904

    Sofia, 1113

  • Teva Investigational Site 5903

    Sofia, 1309

  • Teva Investigational Site 5900

    Sofia, 1606

  • Teva Investigational Site 5905

    Sofia, 1606

  • Teva Investigational Site 5902

    Varna, 9010

Other trials in Bulgaria

France6 sites

  • Teva Investigational Site 3525

    Besançon, 25030

  • Teva Investigational Site 3527

    Bron, 69677

  • Teva Investigational Site 3526

    Clermont-Ferrand, 63003

  • Teva Investigational Site 3524

    Lille, 59037

  • Teva Investigational Site 3528

    Marseille, 13385

  • Teva Investigational Site 3529

    Rennes, 35033

Other trials in France

Romania5 sites

  • Teva Investigational Site 5208

    Bucharest, 011461

  • Teva Investigational Site 5210

    Cluj-Napoca, 400437

  • Teva Investigational Site 5212

    Constanța, 900123

  • Teva Investigational Site 5211

    Târgu Mureş, 540136

  • Teva Investigational Site 5209

    Timișoara, 300736

Other trials in Romania

Ukraine5 sites

  • Teva Investigational Site 5803

    Dnipropetrovsk, 49027

  • Teva Investigational Site 5802

    Kyiv, 03110

  • Teva Investigational Site 5804

    Kyiv, 03115

  • Teva Investigational Site 5800

    Lviv, 79010

  • Teva Investigational Site 5801

    Vinnytsia, 21005

Other trials in Ukraine

Hungary4 sites

  • Teva Investigational Site 5115

    Budapest, H-1145

  • Teva Investigational Site 5114

    Debrecen, 4043

  • Teva Investigational Site 5116

    Miskolc, 3526

  • Teva Investigational Site 5117

    Veszprém, H-8200

Other trials in Hungary

Israel4 sites

  • Teva Investigational Site 8031

    Haifa, 3436212

  • Teva Investigational Site 8030

    Jerusalem, 9112001

  • Teva Investigational Site 8033

    Ramat Gan, 5262160

  • Teva Investigational Site 8032

    Tel Aviv, 78278

Other trials in Israel

Austria3 sites

  • Teva Investigational Site 3300

    Klagenfurt, 9020

  • Teva Investigational Site 3303

    Linz, A-4021

  • Teva Investigational Site 3302

    Sankt Pölten, 3100

Other trials in Austria

Sweden3 sites

  • Teva Investigational Site 4204

    Stockholm, 14186

  • Teva Investigational Site 4205

    Stockholm, 17176

  • Teva Investigational Site 4206

    Stockholm, 18288

Other trials in Sweden

United Kingdom3 sites

  • Teva Investigational Site 3425

    Liverpool, L9 7LJ

  • Teva Investigational Site 3424

    London, E1 2AT

  • Teva Investigational Site 3422

    Sheffield, S10 2JF

Other trials in United Kingdom

Czechia2 sites

  • Teva Investigational Site 5417

    Olomouc, 779 00

  • Teva Investigational Site 5416

    Ostrava - Poruba, 708 52

Other trials in Czechia

Estonia2 sites

  • Teva Investigational Site 5504

    Tallinn, EE-10617

  • Teva Investigational Site 5505

    Tartu, EE-51014

Other trials in Estonia

Georgia2 sites

  • Teva Investigational Site 8100

    Tbilisi, 0112

  • Teva Investigational Site 8101

    Tbilisi, 0179

Other trials in Georgia

Lithuania2 sites

  • Teva Investigational Site 5704

    Kaunas, 50009

  • Teva Investigational Site 5705

    Šiauliai, 76231

Other trials in Lithuania

Netherlands2 sites

  • Teva Investigational Site 3810

    Nieuwegein, 3430 EM

  • Teva Investigational Site 3809

    Nijmegen, 6525 GC

Other trials in Netherlands

Serbia2 sites

  • Teva Investigational Site 6100

    Belgrade, 11000

  • Teva Investigational Site 6102

    Niš, 18 000

Other trials in Serbia

Turkey (Türkiye)1 site

  • Teva Investigational Site 8201

    Izmir, 35340

Other trials in Turkey (Türkiye)

About this study

Official title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

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.

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 NCT00988052
Study groupRoleWhat they receive
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 7.64 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 low: <=45 and decrease >=30 beats/minute
    • Pulse rate high: >=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

    Measured: Day 1 up to 7.64 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: Day 1 up to 7.64 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: Day 1 up to 7.64 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: Day 1 up to 7.64 years

Timeline

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

  1. First posted1 Oct 2009 (estimated)
  2. Study start10 Nov 2009
  3. Primary completion1 Jul 2017
  4. Study completion1 Jul 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
839 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988052
Sponsor's protocol ID
MS-LAQ-301E
Other IDs
2009-012989-30, 2009
Status last verified
Dec 2021
First submitted
28 Sep 2009
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 135 sites in 23 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 135 sites in United States, Germany, Spain, Russia, Italy and 18 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 8 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 7.64 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 NCT00988052.

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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