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The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Laquinimod

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS) score of 0 to 5.5 in both screening and randomization visits.
Participants must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization.
Participants must have experienced at least one documented relapse in the 12 months prior to randomization.
Participants must have disease duration of not more than 15 years.
Women of child-bearing potential (for example, women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication.
- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

Participants with progressive forms of MS.
Participants with neuromyelitis optica.
Use of experimental or investigational drugs and/or participation in drug clinical studies within the 6 months prior to randomization.
Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide, within 6 months prior to randomization.
Use of either of the following within 2 years prior to randomization visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.
Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins within 2 months prior to randomization.
Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).
Previous use of laquinimod.
Previous total body irradiation or total lymphoid irradiation.
Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to randomization.
Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.
Pregnancy or breastfeeding.
A known history of sensitivity to gadolinium (Gd).
Inability to successfully undergo magnetic resonance imaging (MRI) scanning.
Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization.
- Additional criteria apply, please contact the investigator for more information.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Placebo-Controlled Phase: Placebo

Placebo-Controlled Phase: Laquinimod 0.6 mg

Placebo-Controlled Phase: Laquinimod 1.2 mg

Active Treatment Phase: Laquinimod 0.6 mg

Active Treatment Phase: Laquinimod 1.2 mg

Active Treatment Phase: Off Drug

Arm Description

Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.

Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.

Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.

Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.

Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.

Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.

Outcomes

Primary Outcome Measures

Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)

Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.

Secondary Outcome Measures

Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15

Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.

Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)

Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)

Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)

Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.

Full Information

NCT ID

NCT01707992

First Posted

September 28, 2012

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01707992

Brief Title

The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

Acronym

CONCERTO

Official Title

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

February 20, 2013 (Actual)

Primary Completion Date

April 13, 2015 (Actual)

Study Completion Date

July 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo-Controlled Phase: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.

Arm Title

Placebo-Controlled Phase: Laquinimod 0.6 mg

Arm Type

Experimental

Arm Description

Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.

Arm Title

Placebo-Controlled Phase: Laquinimod 1.2 mg

Arm Type

Experimental

Arm Description

Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.

Arm Title

Active Treatment Phase: Laquinimod 0.6 mg

Arm Type

Experimental

Arm Description

Arm Title

Active Treatment Phase: Laquinimod 1.2 mg

Arm Type

Experimental

Arm Description

Arm Title

Active Treatment Phase: Off Drug

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Laquinimod

Intervention Description

Laquinimod will be administered as per the dose and schedule specified in the respective arms.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.

Primary Outcome Measure Information:

Title

Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)

Description

Time Frame

Baseline to Month 24

Secondary Outcome Measure Information:

Title

Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15

Description

Time Frame

Baseline, Month 15

Title

Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)

Description

Time Frame

Baseline to Month 24

Title

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)

Description

Time Frame

Baseline to Month 24

Title

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)

Description

Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.

Time Frame

Baseline to Month 24

Other Pre-specified Outcome Measures:

Title

Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.

Time Frame

Baseline up to Month 24

Title

Active-Treatment Phase: Number of Participants With AEs

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.

Time Frame

Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase

Title

Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities

Description

Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (>=) 120 beats per minute (bpm) and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 millimeters of mercury (mmHg) and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.

Time Frame

Baseline up to Week 24

Title

Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities

Description

Clinically significant vital signs abnormalities included: Pulse rate: >=120 bpm and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 mmHg and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.

Time Frame

Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase

Title

Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters

Description

ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.

Time Frame

Baseline, Endpoint (Month 24)

Title

Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters

Description

ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.

Time Frame

Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)

Title

Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry

Description

Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)>=3 * upper limit of normal (ULN); Fibrinogen >=6 grams per liter (gm/L); Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L.

Time Frame

Baseline up to Month 24

Title

Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry

Description

Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)>=3 * ULN; Fibrinogen >=6 gm/L; Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin >=28 micromols per liter (micromols/L); Creatinine >=117 micromols/L; Albumin <=25 gm/L.

Time Frame

Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase

Title

Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values

Description

Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5 grams per deciliter (gm/dL) in males and <=10 gm/dL in females; White blood cells (WBCs) count <=2.5 and >=21*10^9 per liter (L); Absolute neutrophil count (ANC) <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.

Time Frame

Baseline up to Month 24

Title

Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values

Description

Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5, >=20 gm/dL in males, and <=10, >=18.5 gm/dL in females; WBCs count <=2.5 and >=21*10^9 per L; ANC <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.

Time Frame

Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course. Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS) score of 0 to 5.5 in both screening and randomization visits. Participants must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization. Participants must have experienced at least one documented relapse in the 12 months prior to randomization. Participants must have disease duration of not more than 15 years. Women of child-bearing potential (for example, women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication. Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: Participants with progressive forms of MS. Participants with neuromyelitis optica. Use of experimental or investigational drugs and/or participation in drug clinical studies within the 6 months prior to randomization. Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide, within 6 months prior to randomization. Use of either of the following within 2 years prior to randomization visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab. Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization. Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins within 2 months prior to randomization. Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization. Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®). Previous use of laquinimod. Previous total body irradiation or total lymphoid irradiation. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to randomization. Use of inducers of CYP3A4 within 2 weeks prior to randomization visit. Pregnancy or breastfeeding. A known history of sensitivity to gadolinium (Gd). Inability to successfully undergo magnetic resonance imaging (MRI) scanning. Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization. Additional criteria apply, please contact the investigator for more information.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 10329

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Teva Investigational Site 10349

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Teva Investigational Site 10342

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741-3537

Country

United States

Facility Name

Teva Investigational Site 10310

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Teva Investigational Site 10307

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Teva Investigational Site 10334

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Teva Investigational Site 10332

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Teva Investigational Site 10316

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

Facility Name

Teva Investigational Site 10341

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Teva Investigational Site 10308

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Teva Investigational Site 10315

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Teva Investigational Site 10323

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Teva Investigational Site 10350

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 10345

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Teva Investigational Site 10343

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Teva Investigational Site 10339

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46805

Country

United States

Facility Name

Teva Investigational Site 10348

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

Teva Investigational Site 10338

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Teva Investigational Site 10346

City

Advance

State/Province

North Carolina

ZIP/Postal Code

27006

Country

United States

Facility Name

Teva Investigational Site 10347

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Teva Investigational Site 10309

City

Bellevue

State/Province

Ohio

ZIP/Postal Code

44811

Country

United States

Facility Name

Teva Investigational Site 10317

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

Teva Investigational Site 10325

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Teva Investigational Site 10340

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

Teva Investigational Site 10331

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Teva Investigational Site 10313

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Teva Investigational Site 10324

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Teva Investigational Site 10318

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Teva Investigational Site 10319

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Teva Investigational Site 10330

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

Teva Investigational Site 10311

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Teva Investigational Site 10335

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Teva Investigational Site 33013

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Facility Name

Teva Investigational Site 33014

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Teva Investigational Site 33016

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Teva Investigational Site 33015

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Teva Investigational Site 68010

City

Gomel

ZIP/Postal Code

246029

Country

Belarus

Facility Name

Teva Investigational Site 68013

City

Grodno

ZIP/Postal Code

230027

Country

Belarus

Facility Name

Teva Investigational Site 68012

City

Minsk

ZIP/Postal Code

220026

Country

Belarus

Facility Name

Teva Investigational Site 68009

City

Minsk

ZIP/Postal Code

220114

Country

Belarus

Facility Name

Teva Investigational Site 68008

City

Minsk

ZIP/Postal Code

220116

Country

Belarus

Facility Name

Teva Investigational Site 68011

City

Vitebsk

ZIP/Postal Code

210023

Country

Belarus

Facility Name

Teva Investigational Site 37023

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Teva Investigational Site 37024

City

Sijsele

ZIP/Postal Code

8340

Country

Belgium

Facility Name

Teva Investigational Site 69008

City

Mostar

ZIP/Postal Code

88000

Country

Bosnia and Herzegovina

Facility Name

Teva Investigational Site 69006

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

Teva Investigational Site 69009

City

Tuzla

ZIP/Postal Code

75000

Country

Bosnia and Herzegovina

Facility Name

Teva Investigational Site 59039

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 59040

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 59060

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 59062

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Teva Investigational Site 59061

City

Ruse

ZIP/Postal Code

7003

Country

Bulgaria

Facility Name

Teva Investigational Site 59055

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Teva Investigational Site 59048

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Teva Investigational Site 59052

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Teva Investigational Site 59057

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Teva Investigational Site 59050

City

Sofia

ZIP/Postal Code

1142

Country

Bulgaria

Facility Name

Teva Investigational Site 59044

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Teva Investigational Site 59063

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Teva Investigational Site 59038

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 59043

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 59058

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 59041

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Teva Investigational Site 59042

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 59054

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 59059

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 59045

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

Teva Investigational Site 59049

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

Teva Investigational Site 59046

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Teva Investigational Site 59051

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Teva Investigational Site 59053

City

Veliko Tarnovo

ZIP/Postal Code

5100

Country

Bulgaria

Facility Name

Teva Investigational Site 11013

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z1

Country

Canada

Facility Name

Teva Investigational Site 11014

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 2X6

Country

Canada

Facility Name

Teva Investigational Site 11015

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Teva Investigational Site 11016

City

Saskatoon

ZIP/Postal Code

S7K 0M7

Country

Canada

Facility Name

Teva Investigational Site 60010

City

Osijek

ZIP/Postal Code

31 000

Country

Croatia

Facility Name

Teva Investigational Site 60011

City

Varazdin

ZIP/Postal Code

42000

Country

Croatia

Facility Name

Teva Investigational Site 60009

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Teva Investigational Site 54042

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Teva Investigational Site 54043

City

Havirov

ZIP/Postal Code

736 01

Country

Czechia

Facility Name

Teva Investigational Site 54047

City

Hradec Kralove 3

ZIP/Postal Code

50003

Country

Czechia

Facility Name

Teva Investigational Site 54046

City

Jihlava

ZIP/Postal Code

58633

Country

Czechia

Facility Name

Teva Investigational Site 54044

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Teva Investigational Site 54045

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Teva Investigational Site 54049

City

Praha 10

ZIP/Postal Code

100 31

Country

Czechia

Facility Name

Teva Investigational Site 54041

City

Praha

ZIP/Postal Code

104 00

Country

Czechia

Facility Name

Teva Investigational Site 54048

City

Teplice

ZIP/Postal Code

415 29

Country

Czechia

Facility Name

Teva Investigational Site 55005

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

Teva Investigational Site 55008

City

Tallinn

ZIP/Postal Code

EE-10138

Country

Estonia

Facility Name

Teva Investigational Site 55006

City

Tallinn

ZIP/Postal Code

EE-10617

Country

Estonia

Facility Name

Teva Investigational Site 55007

City

Tartu

ZIP/Postal Code

EE-51014

Country

Estonia

Facility Name

Teva Investigational Site 35075

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Teva Investigational Site 35077

City

Dijon

Country

France

Facility Name

Teva Investigational Site 35073

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Teva Investigational Site 35076

City

Lyon cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Teva Investigational Site 35079

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Teva Investigational Site 81018

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

Teva Investigational Site 81014

City

Tbilisi

ZIP/Postal Code

0141

Country

Georgia

Facility Name

Teva Investigational Site 81015

City

Tbilisi

ZIP/Postal Code

0179

Country

Georgia

Facility Name

Teva Investigational Site 81019

City

Tbilisi

ZIP/Postal Code

0179

Country

Georgia

Facility Name

Teva Investigational Site 81017

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Facility Name

Teva Investigational Site 81016

City

Tbilisi

ZIP/Postal Code

0194

Country

Georgia

Facility Name

Teva Investigational Site 32199

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Teva Investigational Site 32195

City

Berg

ZIP/Postal Code

82335

Country

Germany

Facility Name

Teva Investigational Site 32200

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Teva Investigational Site 32186

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Teva Investigational Site 32176

City

Berlin

ZIP/Postal Code

10625

Country

Germany

Facility Name

Teva Investigational Site 32174

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Teva Investigational Site 32198

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Teva Investigational Site 32177

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Teva Investigational Site 32193

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Teva Investigational Site 32184

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Teva Investigational Site 32189

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Teva Investigational Site 32203

City

Giessen

ZIP/Postal Code

35385

Country

Germany

Facility Name

Teva Investigational Site 32202

City

Goettigen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Teva Investigational Site 32196

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Teva Investigational Site 32181

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Teva Investigational Site 32179

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

Teva Investigational Site 32182

City

Hannover

ZIP/Postal Code

30171

Country

Germany

Facility Name

Teva Investigational Site 32175

City

Ibbenburen

ZIP/Postal Code

49477

Country

Germany

Facility Name

Teva Investigational Site 32201

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Teva Investigational Site 32183

City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Teva Investigational Site 32190

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Teva Investigational Site 32185

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Teva Investigational Site 32191

City

Rostock

ZIP/Postal Code

18147

Country

Germany

Facility Name

Teva Investigational Site 32194

City

Teupitz

ZIP/Postal Code

15755

Country

Germany

Facility Name

Teva Investigational Site 32173

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Teva Investigational Site 32197

City

Wermsdorf

ZIP/Postal Code

04773

Country

Germany

Facility Name

Teva Investigational Site 32188

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Teva Investigational Site 63027

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Teva Investigational Site 63024

City

Athens

ZIP/Postal Code

11525

Country

Greece

Facility Name

Teva Investigational Site 63029

City

Chaidari

ZIP/Postal Code

12462

Country

Greece

Facility Name

Teva Investigational Site 63026

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Teva Investigational Site 63030

City

Larisa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Teva Investigational Site 63025

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Teva Investigational Site 63028

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Teva Investigational Site 51046

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Teva Investigational Site 51043

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Teva Investigational Site 51045

City

Eger

ZIP/Postal Code

H-3300

Country

Hungary

Facility Name

Teva Investigational Site 51044

City

Kaposvar

ZIP/Postal Code

H-7400

Country

Hungary

Facility Name

Teva Investigational Site 80023

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Teva Investigational Site 80024

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Teva Investigational Site 80020

City

Ramat Gan

ZIP/Postal Code

5262160

Country

Israel

Facility Name

Teva Investigational Site 80021

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Teva Investigational Site 30037

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

Teva Investigational Site 30031

City

Castelfiorentino

ZIP/Postal Code

50051

Country

Italy

Facility Name

Teva Investigational Site 30030

City

Cefalu

ZIP/Postal Code

90015

Country

Italy

Facility Name

Teva Investigational Site 30032

City

Chieti

ZIP/Postal Code

66100

Country

Italy

Facility Name

Teva Investigational Site 30024

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Teva Investigational Site 30029

City

Gallarate

ZIP/Postal Code

21013

Country

Italy

Facility Name

Teva Investigational Site 30023

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Teva Investigational Site 30039

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Teva Investigational Site 30034

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Teva Investigational Site 30027

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Teva Investigational Site 30028

City

Rome

ZIP/Postal Code

00149

Country

Italy

Facility Name

Teva Investigational Site 30025

City

Rome

ZIP/Postal Code

00163

Country

Italy

Facility Name

Teva Investigational Site 30026

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Teva Investigational Site 30035

City

Rome

ZIP/Postal Code

00178

Country

Italy

Facility Name

Teva Investigational Site 30040

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Teva Investigational Site 87001

City

Goyang-si

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87003

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87002

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Teva Investigational Site 56006

City

Riga

ZIP/Postal Code

1038

Country

Latvia

Facility Name

Teva Investigational Site 56005

City

Riga

ZIP/Postal Code

LV-1005

Country

Latvia

Facility Name

Teva Investigational Site 70006

City

Chisinau

ZIP/Postal Code

2001

Country

Moldova, Republic of

Facility Name

Teva Investigational Site 70005

City

Chisinau

ZIP/Postal Code

2024

Country

Moldova, Republic of

Facility Name

Teva Investigational Site 70008

City

Chisinau

ZIP/Postal Code

2028

Country

Moldova, Republic of

Facility Name

Teva Investigational Site 66002

City

Podgorica

ZIP/Postal Code

20000

Country

Montenegro

Facility Name

Teva Investigational Site 65010

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

Teva Investigational Site 65011

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

Teva Investigational Site 65012

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

Teva Investigational Site 53066

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Teva Investigational Site 53071

City

Bialystok

ZIP/Postal Code

15-402

Country

Poland

Facility Name

Teva Investigational Site 53085

City

Bydgoszcz

ZIP/Postal Code

85-654

Country

Poland

Facility Name

Teva Investigational Site 53084

City

Czestochowa

ZIP/Postal Code

42-280

Country

Poland

Facility Name

Teva Investigational Site 53069

City

Gdansk

ZIP/Postal Code

80-299

Country

Poland

Facility Name

Teva Investigational Site 53083

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Teva Investigational Site 53067

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Teva Investigational Site 53078

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Teva Investigational Site 53080

City

Katowice

ZIP/Postal Code

40-555

Country

Poland

Facility Name

Teva Investigational Site 53081

City

Katowice

ZIP/Postal Code

40-650

Country

Poland

Facility Name

Teva Investigational Site 53073

City

Katowice

ZIP/Postal Code

40-684

Country

Poland

Facility Name

Teva Investigational Site 53070

City

Katowice

ZIP/Postal Code

40-749

Country

Poland

Facility Name

Teva Investigational Site 53074

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Teva Investigational Site 53064

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Teva Investigational Site 53065

City

Konstancin-Jeziorna

ZIP/Postal Code

05-510

Country

Poland

Facility Name

Teva Investigational Site 53072

City

Koscierzyna

ZIP/Postal Code

83-400

Country

Poland

Facility Name

Teva Investigational Site 53063

City

Lodz

ZIP/Postal Code

90-324

Country

Poland

Facility Name

Teva Investigational Site 53079

City

Olsztyn

ZIP/Postal Code

10-560

Country

Poland

Facility Name

Teva Investigational Site 53068

City

Plewiska

ZIP/Postal Code

62-064

Country

Poland

Facility Name

Teva Investigational Site 53076

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Teva Investigational Site 52045

City

Balotesti

ZIP/Postal Code

77015

Country

Romania

Facility Name

Teva Investigational Site 52041

City

Bucharest

ZIP/Postal Code

012071

Country

Romania

Facility Name

Teva Investigational Site 52050

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

Teva Investigational Site 52037

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Teva Investigational Site 52034

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

Teva Investigational Site 52040

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Teva Investigational Site 52036

City

Cluj-Napoca

ZIP/Postal Code

400437

Country

Romania

Facility Name

Teva Investigational Site 52038

City

Constanta

ZIP/Postal Code

900123

Country

Romania

Facility Name

Teva Investigational Site 52044

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Teva Investigational Site 52048

City

Craiova

ZIP/Postal Code

200473

Country

Romania

Facility Name

Teva Investigational Site 52049

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Teva Investigational Site 52042

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Teva Investigational Site 52039

City

Oradea

ZIP/Postal Code

410108

Country

Romania

Facility Name

Teva Investigational Site 52047

City

Piatra-Neamt

ZIP/Postal Code

610136

Country

Romania

Facility Name

Teva Investigational Site 52046

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

Teva Investigational Site 52035

City

Targu Mures

Country

Romania

Facility Name

Teva Investigational Site 52043

City

Timisoara

ZIP/Postal Code

100182

Country

Romania

Facility Name

Teva Investigational Site 50130

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Teva Investigational Site 50129

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Teva Investigational Site 50208

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

Teva Investigational Site 50148

City

Kemerovo

ZIP/Postal Code

650061

Country

Russian Federation

Facility Name

Teva Investigational Site 50144

City

Krasnodar

ZIP/Postal Code

350012

Country

Russian Federation

Facility Name

Teva Investigational Site 50147

City

Moscow

ZIP/Postal Code

119021

Country

Russian Federation

Facility Name

Teva Investigational Site 50124

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Teva Investigational Site 50133

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

Teva Investigational Site 50146

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Teva Investigational Site 50141

City

Nizhny Novgorod

ZIP/Postal Code

603076

Country

Russian Federation

Facility Name

Teva Investigational Site 50128

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Teva Investigational Site 50131

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Teva Investigational Site 50127

City

Perm

ZIP/Postal Code

614990

Country

Russian Federation

Facility Name

Teva Investigational Site 50143

City

Rostov-on-Don

ZIP/Postal Code

344015

Country

Russian Federation

Facility Name

Teva Investigational Site 50149

City

Rostov-on-Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Teva Investigational Site 50126

City

Saint Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Facility Name

Teva Investigational Site 50140

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Teva Investigational Site 50138

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Teva Investigational Site 50135

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

Teva Investigational Site 50136

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Teva Investigational Site 50137

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Teva Investigational Site 50125

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Teva Investigational Site 50139

City

Tyumen

ZIP/Postal Code

625000

Country

Russian Federation

Facility Name

Teva Investigational Site 50134

City

Ufa

ZIP/Postal Code

450007

Country

Russian Federation

Facility Name

Teva Investigational Site 50132

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Facility Name

Teva Investigational Site 50142

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Teva Investigational Site 61025

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 61027

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 61024

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Teva Investigational Site 61018

City

Cacak

ZIP/Postal Code

32000

Country

Serbia

Facility Name

Teva Investigational Site 61015

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Teva Investigational Site 61014

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Teva Investigational Site 61019

City

Sombor

ZIP/Postal Code

25000

Country

Serbia

Facility Name

Teva Investigational Site 61016

City

Subotica

ZIP/Postal Code

24000

Country

Serbia

Facility Name

Teva Investigational Site 61017

City

Uzice

ZIP/Postal Code

31000

Country

Serbia

Facility Name

Teva Investigational Site 61022

City

Valjevo

ZIP/Postal Code

14000

Country

Serbia

Facility Name

Teva Investigational Site 61026

City

Vrbas

ZIP/Postal Code

21460

Country

Serbia

Facility Name

Teva Investigational Site 61021

City

Zrenjanin

ZIP/Postal Code

23000

Country

Serbia

Facility Name

Teva Investigational Site 62012

City

Hlohovec

ZIP/Postal Code

92001

Country

Slovakia

Facility Name

Teva Investigational Site 62013

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Facility Name

Teva Investigational Site 31035

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Teva Investigational Site 31030

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Teva Investigational Site 31031

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

Teva Investigational Site 31036

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Teva Investigational Site 31032

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Teva Investigational Site 31034

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Teva Investigational Site 31033

City

Navarro

ZIP/Postal Code

31008

Country

Spain

Facility Name

Teva Investigational Site 31039

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Teva Investigational Site 31037

City

Salt

ZIP/Postal Code

17190

Country

Spain

Facility Name

Teva Investigational Site 58087

City

Chernihiv

ZIP/Postal Code

14001

Country

Ukraine

Facility Name

Teva Investigational Site 58083

City

Chernivtsi

ZIP/Postal Code

58018

Country

Ukraine

Facility Name

Teva Investigational Site 58077

City

Dnipropetrovsk

ZIP/Postal Code

49044

Country

Ukraine

Facility Name

Teva Investigational Site 58088

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Teva Investigational Site 58076

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

Teva Investigational Site 58116

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Teva Investigational Site 58084

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

Teva Investigational Site 58089

City

Kiev

ZIP/Postal Code

04112

Country

Ukraine

Facility Name

Teva Investigational Site 58073

City

Kyiv

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Teva Investigational Site 58078

City

Kyiv

ZIP/Postal Code

03110

Country

Ukraine

Facility Name

Teva Investigational Site 58081

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Teva Investigational Site 58115

City

Lviv

ZIP/Postal Code

79013

Country

Ukraine

Facility Name

Teva Investigational Site 58086

City

Lviv

ZIP/Postal Code

79059

Country

Ukraine

Facility Name

Teva Investigational Site 58074

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Teva Investigational Site 58085

City

Odessa

ZIP/Postal Code

65014

Country

Ukraine

Facility Name

Teva Investigational Site 58082

City

Poltava

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

Teva Investigational Site 58080

City

Simferopol

ZIP/Postal Code

95000

Country

Ukraine

Facility Name

Teva Investigational Site 58072

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Teva Investigational Site 58079

City

Zaporizhzhya

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Teva Investigational Site 58075

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Teva Investigational Site 34015

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Teva Investigational Site 34011

City

Liverpool

ZIP/Postal Code

B0T 1K0

Country

United Kingdom

Facility Name

Teva Investigational Site 34010

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

Teva Investigational Site 34019

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Teva Investigational Site 34016

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Teva Investigational Site 34017

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Teva Investigational Site 34013

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34378456

Citation

Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2022 Apr;28(4):608-619. doi: 10.1177/13524585211032803. Epub 2021 Aug 11.

Results Reference

derived

Learn more about this trial

The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

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The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial