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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Laquinimod
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Relapsing Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
  2. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the study and up to 30 days after the last dose of the study drug..
  3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.

Exclusion Criteria:

  1. Premature discontinuation from the MS-LAQ-301 study, for any reason.
  2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
  3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-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.
  4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).

Sites / Locations

  • Teva Investigational Site 1076
  • Teva Investigational Site 1090
  • Teva Investigational Site 1088
  • Teva Investigational Site 1102
  • Teva Investigational Site 1081
  • Teva Investigational Site 1083
  • Teva Investigational Site 1086
  • Teva Investigational Site 1101
  • Teva Investigational Site 1096
  • Teva Investigational Site 1093
  • Teva Investigational Site 1098
  • Teva Investigational Site 1082
  • Teva Investigational Site 1073
  • Teva Investigational Site 1097
  • Teva Investigational Site 1084
  • Teva Investigational Site 1092
  • Teva Investigational Site 1100
  • Teva Investigational Site 1075
  • Teva Investigational Site 1078
  • Teva Investigational Site 1085
  • Teva Investigational Site 3300
  • Teva Investigational Site 3303
  • Teva Investigational Site 3302
  • Teva Investigational Site 5901
  • Teva Investigational Site 5904
  • Teva Investigational Site 5903
  • Teva Investigational Site 5900
  • Teva Investigational Site 5905
  • Teva Investigational Site 5902
  • Teva Investigational Site 1132
  • Teva Investigational Site 1126
  • Teva Investigational Site 1128
  • Teva Investigational Site 1134
  • Teva Investigational Site 1130
  • Teva Investigational Site 1129
  • Teva Investigational Site 1131
  • Teva Investigational Site 5417
  • Teva Investigational Site 5416
  • Teva Investigational Site 5504
  • Teva Investigational Site 5505
  • Teva Investigational Site 3525
  • Teva Investigational Site 3527
  • Teva Investigational Site 3526
  • Teva Investigational Site 3524
  • Teva Investigational Site 3528
  • Teva Investigational Site 3529
  • Teva Investigational Site 8100
  • Teva Investigational Site 8101
  • Teva Investigational Site 3247
  • Teva Investigational Site 3241
  • Teva Investigational Site 3238
  • Teva Investigational Site 3248
  • Teva Investigational Site 3245
  • Teva Investigational Site 3237
  • Teva Investigational Site 3242
  • Teva Investigational Site 3240
  • Teva Investigational Site 3249
  • Teva Investigational Site 3236
  • Teva Investigational Site 3246
  • Teva Investigational Site 3239
  • Teva Investigational Site 3243
  • Teva Investigational Site 3251
  • Teva Investigational Site 3250
  • Teva Investigational Site 3244
  • Teva Investigational Site 5115
  • Teva Investigational Site 5114
  • Teva Investigational Site 5116
  • Teva Investigational Site 5117
  • Teva Investigational Site 8031
  • Teva Investigational Site 8030
  • Teva Investigational Site 8033
  • Teva Investigational Site 8032
  • Teva Investigational Site 3044
  • Teva Investigational Site 3045
  • Teva Investigational Site 3042
  • Teva Investigational Site 3046
  • Teva Investigational Site 3038
  • Teva Investigational Site 555
  • Teva Investigational Site 3039
  • Teva Investigational Site 3041
  • Teva Investigational Site 3040
  • Teva Investigational Site 5704
  • Teva Investigational Site 5705
  • Teva Investigational Site 3810
  • Teva Investigational Site 3809
  • Teva Investigational Site 5322
  • Teva Investigational Site 5320
  • Teva Investigational Site 5316
  • Teva Investigational Site 5318
  • Teva Investigational Site 5319
  • Teva Investigational Site 5317
  • Teva Investigational Site 5315
  • Teva Investigational Site 5325
  • Teva Investigational Site 5208
  • Teva Investigational Site 5210
  • Teva Investigational Site 5212
  • Teva Investigational Site 5211
  • Teva Investigational Site 5209
  • Teva Investigational Site 5029
  • Teva Investigational Site 5021
  • Teva Investigational Site 5028
  • Teva Investigational Site 5027
  • Teva Investigational Site 5030
  • Teva Investigational Site 5022
  • Teva Investigational Site 5025
  • Teva Investigational Site 5024
  • Teva Investigational Site 5023
  • Teva Investigational Site 5026
  • Teva Investigational Site 6100
  • Teva Investigational Site 6102
  • Teva Investigational Site 3132
  • Teva Investigational Site 3134
  • Teva Investigational Site 3144
  • Teva Investigational Site 3140
  • Teva Investigational Site 3142
  • Teva Investigational Site 3135
  • Teva Investigational Site 3133
  • Teva Investigational Site 3146
  • Teva Investigational Site 3137
  • Teva Investigational Site 3138
  • Teva Investigational Site 3136
  • Teva Investigational Site 3139
  • Teva Investigational Site 3143
  • Teva Investigational Site 4204
  • Teva Investigational Site 4205
  • Teva Investigational Site 4206
  • Teva Investigational Site 8201
  • Teva Investigational Site 5803
  • Teva Investigational Site 5802
  • Teva Investigational Site 5804
  • Teva Investigational Site 5800
  • Teva Investigational Site 5801
  • Teva Investigational Site 3425
  • Teva Investigational Site 3424
  • Teva Investigational Site 3422

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laquinimod

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
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)

Full Information

First Posted
September 28, 2009
Last Updated
December 7, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00988052
Brief Title
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
Study Start Date
November 10, 2009 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 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
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laquinimod
Arm Type
Experimental
Arm Description
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Laquinimod
Intervention Description
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Primary Outcome Measure Information:
Title
Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Day 1 up to 7.64 years
Secondary Outcome Measure Information:
Title
Participants With Potentially Clinically Significant Abnormal Vital Signs
Description
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
Time Frame
Day 1 up to 7.64 years
Title
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description
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
Time Frame
Day 1 up to 7.64 years
Title
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description
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.
Time Frame
Day 1 up to 7.64 years
Title
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Description
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)
Time Frame
Day 1 up to 7.64 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giancarlo Comi, Prof., MD
Organizational Affiliation
U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teva Investigational Site 1076
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Teva Investigational Site 1090
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Teva Investigational Site 1088
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Teva Investigational Site 1102
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Teva Investigational Site 1081
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Teva Investigational Site 1083
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Teva Investigational Site 1086
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
Teva Investigational Site 1101
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Teva Investigational Site 1096
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Teva Investigational Site 1093
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Teva Investigational Site 1098
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Teva Investigational Site 1082
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Teva Investigational Site 1073
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Teva Investigational Site 1097
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Teva Investigational Site 1084
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Teva Investigational Site 1092
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Teva Investigational Site 1100
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Teva Investigational Site 1075
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Teva Investigational Site 1078
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Teva Investigational Site 1085
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Teva Investigational Site 3300
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Teva Investigational Site 3303
City
Linz
ZIP/Postal Code
A-4021
Country
Austria
Facility Name
Teva Investigational Site 3302
City
Sankt Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Teva Investigational Site 5901
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Teva Investigational Site 5904
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Teva Investigational Site 5903
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Teva Investigational Site 5900
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5905
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5902
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Teva Investigational Site 1132
City
Bedford
State/Province
Nova Scotia
ZIP/Postal Code
B4A 1A9
Country
Canada
Facility Name
Teva Investigational Site 1126
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Teva Investigational Site 1128
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Teva Investigational Site 1134
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Teva Investigational Site 1130
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Teva Investigational Site 1129
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Teva Investigational Site 1131
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Teva Investigational Site 5417
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Teva Investigational Site 5416
City
Ostrava - poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Teva Investigational Site 5504
City
Tallinn
ZIP/Postal Code
EE-10617
Country
Estonia
Facility Name
Teva Investigational Site 5505
City
Tartu
ZIP/Postal Code
EE-51014
Country
Estonia
Facility Name
Teva Investigational Site 3525
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Teva Investigational Site 3527
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Teva Investigational Site 3526
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Teva Investigational Site 3524
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Teva Investigational Site 3528
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Teva Investigational Site 3529
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Teva Investigational Site 8100
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Teva Investigational Site 8101
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Teva Investigational Site 3247
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Teva Investigational Site 3241
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Teva Investigational Site 3238
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Teva Investigational Site 3248
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Teva Investigational Site 3245
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Teva Investigational Site 3237
City
Emden
ZIP/Postal Code
26721
Country
Germany
Facility Name
Teva Investigational Site 3242
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Teva Investigational Site 3240
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Teva Investigational Site 3249
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Teva Investigational Site 3236
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Teva Investigational Site 3246
City
Hamburg
ZIP/Postal Code
22417
Country
Germany
Facility Name
Teva Investigational Site 3239
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Teva Investigational Site 3243
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Teva Investigational Site 3251
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Teva Investigational Site 3250
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Teva Investigational Site 3244
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Teva Investigational Site 5115
City
Budapest
ZIP/Postal Code
H-1145
Country
Hungary
Facility Name
Teva Investigational Site 5114
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Teva Investigational Site 5116
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Teva Investigational Site 5117
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Teva Investigational Site 8031
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Teva Investigational Site 8030
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Teva Investigational Site 8033
City
Ramat Gan
ZIP/Postal Code
5262160
Country
Israel
Facility Name
Teva Investigational Site 8032
City
Tel Aviv
ZIP/Postal Code
78278
Country
Israel
Facility Name
Teva Investigational Site 3044
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Teva Investigational Site 3045
City
Fidenza
ZIP/Postal Code
43036
Country
Italy
Facility Name
Teva Investigational Site 3042
City
Gallarate
ZIP/Postal Code
21013
Country
Italy
Facility Name
Teva Investigational Site 3046
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Teva Investigational Site 3038
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Teva Investigational Site 555
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Teva Investigational Site 3039
City
Milano
ZIP/Postal Code
20148
Country
Italy
Facility Name
Teva Investigational Site 3041
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Teva Investigational Site 3040
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Teva Investigational Site 5704
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Teva Investigational Site 5705
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Teva Investigational Site 3810
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Teva Investigational Site 3809
City
Nijmegen
ZIP/Postal Code
6525 GC
Country
Netherlands
Facility Name
Teva Investigational Site 5322
City
Czestochowa
ZIP/Postal Code
42-280
Country
Poland
Facility Name
Teva Investigational Site 5320
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Teva Investigational Site 5316
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Teva Investigational Site 5318
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Teva Investigational Site 5319
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Teva Investigational Site 5317
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Teva Investigational Site 5315
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Teva Investigational Site 5325
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Teva Investigational Site 5208
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Teva Investigational Site 5210
City
Cluj-Napoca
ZIP/Postal Code
400437
Country
Romania
Facility Name
Teva Investigational Site 5212
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Teva Investigational Site 5211
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Teva Investigational Site 5209
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Teva Investigational Site 5029
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Teva Investigational Site 5021
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Teva Investigational Site 5028
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Teva Investigational Site 5027
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Teva Investigational Site 5030
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Teva Investigational Site 5022
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Teva Investigational Site 5025
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Teva Investigational Site 5024
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Teva Investigational Site 5023
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Teva Investigational Site 5026
City
St.Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Teva Investigational Site 6100
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Teva Investigational Site 6102
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Teva Investigational Site 3132
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Teva Investigational Site 3134
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Teva Investigational Site 3144
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Teva Investigational Site 3140
City
Beade-Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Teva Investigational Site 3142
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Teva Investigational Site 3135
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Teva Investigational Site 3133
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Teva Investigational Site 3146
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Teva Investigational Site 3137
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Teva Investigational Site 3138
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Teva Investigational Site 3136
City
Salt
ZIP/Postal Code
17190
Country
Spain
Facility Name
Teva Investigational Site 3139
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Teva Investigational Site 3143
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Teva Investigational Site 4204
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Teva Investigational Site 4205
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Teva Investigational Site 4206
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Teva Investigational Site 8201
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Teva Investigational Site 5803
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Teva Investigational Site 5802
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Teva Investigational Site 5804
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Teva Investigational Site 5800
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Teva Investigational Site 5801
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Teva Investigational Site 3425
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Teva Investigational Site 3424
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Teva Investigational Site 3422
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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