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

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00988052
• Other study ID #: MS-LAQ-301E
• Secondary ID: 2009-012989-30
• Status: Terminated
• Phase: Phase 3
• Start date: November 10, 2009
• Est. completion date: July 1, 2017

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 839
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 ß-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).

Related Conditions & MeSH terms

• Disease Progression
• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Locations

Country	Name	City	State
Austria	Teva Investigational Site 3300	Klagenfurt
Austria	Teva Investigational Site 3303	Linz
Austria	Teva Investigational Site 3302	Sankt Polten
Bulgaria	Teva Investigational Site 5901	Pleven
Bulgaria	Teva Investigational Site 5900	Sofia
Bulgaria	Teva Investigational Site 5903	Sofia
Bulgaria	Teva Investigational Site 5904	Sofia
Bulgaria	Teva Investigational Site 5905	Sofia
Bulgaria	Teva Investigational Site 5902	Varna
Canada	Teva Investigational Site 1132	Bedford	Nova Scotia
Canada	Teva Investigational Site 1130	Greenfield Park	Quebec
Canada	Teva Investigational Site 1126	London	Ontario
Canada	Teva Investigational Site 1129	Montreal	Quebec
Canada	Teva Investigational Site 1128	Ottawa	Ontario
Canada	Teva Investigational Site 1131	Sherbrooke	Quebec
Canada	Teva Investigational Site 1134	Toronto	Ontario
Czechia	Teva Investigational Site 5417	Olomouc
Czechia	Teva Investigational Site 5416	Ostrava - poruba
Estonia	Teva Investigational Site 5504	Tallinn
Estonia	Teva Investigational Site 5505	Tartu
France	Teva Investigational Site 3525	Besancon
France	Teva Investigational Site 3527	Bron Cedex
France	Teva Investigational Site 3526	Clermont-Ferrand Cedex 1
France	Teva Investigational Site 3524	Lille Cedex
France	Teva Investigational Site 3528	Marseille Cedex 5
France	Teva Investigational Site 3529	Rennes Cedex 9
Georgia	Teva Investigational Site 8100	Tbilisi
Georgia	Teva Investigational Site 8101	Tbilisi
Germany	Teva Investigational Site 3247	Bayreuth
Germany	Teva Investigational Site 3238	Berlin
Germany	Teva Investigational Site 3241	Berlin
Germany	Teva Investigational Site 3248	Bochum
Germany	Teva Investigational Site 3245	Dresden
Germany	Teva Investigational Site 3237	Emden
Germany	Teva Investigational Site 3242	Erbach
Germany	Teva Investigational Site 3240	Erfurt
Germany	Teva Investigational Site 3249	Freiburg
Germany	Teva Investigational Site 3236	Hamburg
Germany	Teva Investigational Site 3246	Hamburg
Germany	Teva Investigational Site 3239	Hannover
Germany	Teva Investigational Site 3243	Heidelberg
Germany	Teva Investigational Site 3251	Munster
Germany	Teva Investigational Site 3250	Trier
Germany	Teva Investigational Site 3244	Ulm
Hungary	Teva Investigational Site 5115	Budapest
Hungary	Teva Investigational Site 5114	Debrecen
Hungary	Teva Investigational Site 5116	Miskolc
Hungary	Teva Investigational Site 5117	Veszprem
Israel	Teva Investigational Site 8031	Haifa
Israel	Teva Investigational Site 8030	Jerusalem
Israel	Teva Investigational Site 8033	Ramat Gan
Israel	Teva Investigational Site 8032	Tel Aviv
Italy	Teva Investigational Site 3044	Catania
Italy	Teva Investigational Site 3045	Fidenza
Italy	Teva Investigational Site 3042	Gallarate
Italy	Teva Investigational Site 3046	Grosseto
Italy	Teva Investigational Site 3038	Milano
Italy	Teva Investigational Site 3039	Milano
Italy	Teva Investigational Site 555	Milano
Italy	Teva Investigational Site 3041	Palermo
Italy	Teva Investigational Site 3040	Rome
Lithuania	Teva Investigational Site 5704	Kaunas
Lithuania	Teva Investigational Site 5705	Siauliai
Netherlands	Teva Investigational Site 3810	Nieuwegein
Netherlands	Teva Investigational Site 3809	Nijmegen
Poland	Teva Investigational Site 5322	Czestochowa
Poland	Teva Investigational Site 5320	Gorzow Wielkopolski
Poland	Teva Investigational Site 5316	Katowice
Poland	Teva Investigational Site 5318	Kielce
Poland	Teva Investigational Site 5319	Konskie
Poland	Teva Investigational Site 5317	Krakow
Poland	Teva Investigational Site 5315	Lodz
Poland	Teva Investigational Site 5325	Warszawa
Romania	Teva Investigational Site 5208	Bucharest
Romania	Teva Investigational Site 5210	Cluj-Napoca
Romania	Teva Investigational Site 5212	Constanta
Romania	Teva Investigational Site 5211	Targu-Mures
Romania	Teva Investigational Site 5209	Timisoara
Russian Federation	Teva Investigational Site 5029	Ekaterinburg
Russian Federation	Teva Investigational Site 5021	Moscow
Russian Federation	Teva Investigational Site 5028	Nizhny Novgorod
Russian Federation	Teva Investigational Site 5027	Novosibirsk
Russian Federation	Teva Investigational Site 5030	Perm
Russian Federation	Teva Investigational Site 5022	Saint Petersburg
Russian Federation	Teva Investigational Site 5023	St. Petersburg
Russian Federation	Teva Investigational Site 5024	St. Petersburg
Russian Federation	Teva Investigational Site 5025	St. Petersburg
Russian Federation	Teva Investigational Site 5026	St.Petersburg
Serbia	Teva Investigational Site 6100	Belgrade
Serbia	Teva Investigational Site 6102	Nis
Spain	Teva Investigational Site 3132	Barcelona
Spain	Teva Investigational Site 3134	Barcelona
Spain	Teva Investigational Site 3144	Barcelona
Spain	Teva Investigational Site 3140	Beade-Pontevedra
Spain	Teva Investigational Site 3142	Getafe
Spain	Teva Investigational Site 3135	Lleida
Spain	Teva Investigational Site 3133	Madrid
Spain	Teva Investigational Site 3146	Madrid
Spain	Teva Investigational Site 3137	Murcia
Spain	Teva Investigational Site 3138	Pontevedra
Spain	Teva Investigational Site 3136	Salt
Spain	Teva Investigational Site 3139	Santiago de Compostela
Spain	Teva Investigational Site 3143	Valencia
Sweden	Teva Investigational Site 4204	Stockholm
Sweden	Teva Investigational Site 4205	Stockholm
Sweden	Teva Investigational Site 4206	Stockholm
Turkey	Teva Investigational Site 8201	Izmir
Ukraine	Teva Investigational Site 5803	Dnipropetrovsk
Ukraine	Teva Investigational Site 5802	Kyiv
Ukraine	Teva Investigational Site 5804	Kyiv
Ukraine	Teva Investigational Site 5800	Lviv
Ukraine	Teva Investigational Site 5801	Vinnytsya
United Kingdom	Teva Investigational Site 3425	Liverpool
United Kingdom	Teva Investigational Site 3424	London
United Kingdom	Teva Investigational Site 3422	Sheffield
United States	Teva Investigational Site 1090	Centennial	Colorado
United States	Teva Investigational Site 1084	Dayton	Ohio
United States	Teva Investigational Site 1083	Des Moines	Iowa
United States	Teva Investigational Site 1097	Fargo	North Dakota
United States	Teva Investigational Site 1096	Farmington Hills	Michigan
United States	Teva Investigational Site 1088	Fort Collins	Colorado
United States	Teva Investigational Site 1081	Fort Wayne	Indiana
United States	Teva Investigational Site 1100	Hershey	Pennsylvania
United States	Teva Investigational Site 1086	Kansas City	Kansas
United States	Teva Investigational Site 1101	Lexington	Kentucky
United States	Teva Investigational Site 1075	Lubbock	Texas
United States	Teva Investigational Site 1085	Milwaukee	Wisconsin
United States	Teva Investigational Site 1093	Minneapolis	Minnesota
United States	Teva Investigational Site 1082	New York	New York
United States	Teva Investigational Site 1102	Northbrook	Illinois
United States	Teva Investigational Site 1092	Oklahoma City	Oklahoma
United States	Teva Investigational Site 1076	Phoenix	Arizona
United States	Teva Investigational Site 1098	Saint Louis	Missouri
United States	Teva Investigational Site 1078	San Antonio	Texas
United States	Teva Investigational Site 1073	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Georgia,  Germany,  Hungary,  Israel,  Italy,  Lithuania,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 up to 7.64 years
Secondary	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	Day 1 up to 7.64 years
Secondary	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	Day 1 up to 7.64 years
Secondary	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.	Day 1 up to 7.64 years
Secondary	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)	Day 1 up to 7.64 years