Clinical trial NCT00988052: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 839
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 7.64 years
Secondary outcomes:
measure: Participants With Potentially Clinically Significant Abnormal Vital Signs
timeFrame: Day 1 up to 7.64 years
measure: Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
timeFrame: Day 1 up to 7.64 years
measure: Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
timeFrame: Day 1 up to 7.64 years
measure: Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
timeFrame: Day 1 up to 7.64 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 1076
state: Arizona
city: Centennial
country: United States
facility: Teva Investigational Site 1090
state: Colorado
city: Fort Collins
country: United States
facility: Teva Investigational Site 1088
state: Colorado
city: Northbrook
country: United States
facility: Teva Investigational Site 1102
state: Illinois
city: Fort Wayne
country: United States
facility: Teva Investigational Site 1081
state: Indiana
city: Des Moines
country: United States
facility: Teva Investigational Site 1083
state: Iowa
city: Kansas City
country: United States
facility: Teva Investigational Site 1086
state: Kansas
city: Lexington
country: United States
facility: Teva Investigational Site 1101
state: Kentucky
city: Farmington Hills
country: United States
facility: Teva Investigational Site 1096
state: Michigan
city: Minneapolis
country: United States
facility: Teva Investigational Site 1093
state: Minnesota
city: Saint Louis
country: United States
facility: Teva Investigational Site 1098
state: Missouri
city: New York
country: United States
facility: Teva Investigational Site 1082
state: New York
city: Winston-Salem
country: United States
facility: Teva Investigational Site 1073
state: North Carolina
city: Fargo
country: United States
facility: Teva Investigational Site 1097
state: North Dakota
city: Dayton
country: United States
facility: Teva Investigational Site 1084
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 1092
state: Oklahoma
city: Hershey
country: United States
facility: Teva Investigational Site 1100
state: Pennsylvania
city: Lubbock
country: United States
facility: Teva Investigational Site 1075
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 1078
state: Texas
city: Milwaukee
country: United States
facility: Teva Investigational Site 1085
state: Wisconsin
city: Klagenfurt
country: Austria
facility: Teva Investigational Site 3300
city: Linz
country: Austria
facility: Teva Investigational Site 3303
city: Sankt Polten
country: Austria
facility: Teva Investigational Site 3302
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 5901
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5904
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5903
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5900
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5905
city: Varna
country: Bulgaria
facility: Teva Investigational Site 5902
city: Bedford
country: Canada
facility: Teva Investigational Site 1132
state: Nova Scotia
city: London
country: Canada
facility: Teva Investigational Site 1126
state: Ontario
city: Ottawa
country: Canada
facility: Teva Investigational Site 1128
state: Ontario
city: Toronto
country: Canada
facility: Teva Investigational Site 1134
state: Ontario
city: Greenfield Park
country: Canada
facility: Teva Investigational Site 1130
state: Quebec
city: Montreal
country: Canada
facility: Teva Investigational Site 1129
state: Quebec
city: Sherbrooke
country: Canada
facility: Teva Investigational Site 1131
state: Quebec
city: Olomouc
country: Czechia
facility: Teva Investigational Site 5417
city: Ostrava - poruba
country: Czechia
facility: Teva Investigational Site 5416
city: Tallinn
country: Estonia
facility: Teva Investigational Site 5504
city: Tartu
country: Estonia
facility: Teva Investigational Site 5505
city: Besancon
country: France
facility: Teva Investigational Site 3525
city: Bron Cedex
country: France
facility: Teva Investigational Site 3527
city: Clermont-Ferrand Cedex 1
country: France
facility: Teva Investigational Site 3526
city: Lille Cedex
country: France
facility: Teva Investigational Site 3524
city: Marseille Cedex 5
country: France
facility: Teva Investigational Site 3528
city: Rennes Cedex 9
country: France
facility: Teva Investigational Site 3529
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 8100
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 8101
city: Bayreuth
country: Germany
facility: Teva Investigational Site 3247
city: Berlin
country: Germany
facility: Teva Investigational Site 3241
city: Berlin
country: Germany
facility: Teva Investigational Site 3238
city: Bochum
country: Germany
facility: Teva Investigational Site 3248
city: Dresden
country: Germany
facility: Teva Investigational Site 3245
city: Emden
country: Germany
facility: Teva Investigational Site 3237
city: Erbach
country: Germany
facility: Teva Investigational Site 3242
city: Erfurt
country: Germany
facility: Teva Investigational Site 3240
city: Freiburg
country: Germany
facility: Teva Investigational Site 3249
city: Hamburg
country: Germany
facility: Teva Investigational Site 3236
city: Hamburg
country: Germany
facility: Teva Investigational Site 3246
city: Hannover
country: Germany
facility: Teva Investigational Site 3239
city: Heidelberg
country: Germany
facility: Teva Investigational Site 3243
city: Munster
country: Germany
facility: Teva Investigational Site 3251
city: Trier
country: Germany
facility: Teva Investigational Site 3250
city: Ulm
country: Germany
facility: Teva Investigational Site 3244
city: Budapest
country: Hungary
facility: Teva Investigational Site 5115
city: Debrecen
country: Hungary
facility: Teva Investigational Site 5114
city: Miskolc
country: Hungary
facility: Teva Investigational Site 5116
city: Veszprem
country: Hungary
facility: Teva Investigational Site 5117
city: Haifa
country: Israel
facility: Teva Investigational Site 8031
city: Jerusalem
country: Israel
facility: Teva Investigational Site 8030
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 8033
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 8032
city: Catania
country: Italy
facility: Teva Investigational Site 3044
city: Fidenza
country: Italy
facility: Teva Investigational Site 3045
city: Gallarate
country: Italy
facility: Teva Investigational Site 3042
city: Grosseto
country: Italy
facility: Teva Investigational Site 3046
city: Milano
country: Italy
facility: Teva Investigational Site 3038
city: Milano
country: Italy
facility: Teva Investigational Site 555
city: Milano
country: Italy
facility: Teva Investigational Site 3039
city: Palermo
country: Italy
facility: Teva Investigational Site 3041
city: Rome
country: Italy
facility: Teva Investigational Site 3040
city: Kaunas
country: Lithuania
facility: Teva Investigational Site 5704
city: Siauliai
country: Lithuania
facility: Teva Investigational Site 5705
city: Nieuwegein
country: Netherlands
facility: Teva Investigational Site 3810
city: Nijmegen
country: Netherlands
facility: Teva Investigational Site 3809
city: Czestochowa
country: Poland
facility: Teva Investigational Site 5322
city: Gorzow Wielkopolski
country: Poland
facility: Teva Investigational Site 5320
city: Katowice
country: Poland
facility: Teva Investigational Site 5316
city: Kielce
country: Poland
facility: Teva Investigational Site 5318
city: Konskie
country: Poland
facility: Teva Investigational Site 5319
city: Krakow
country: Poland
facility: Teva Investigational Site 5317
city: Lodz
country: Poland
facility: Teva Investigational Site 5315
city: Warszawa
country: Poland
facility: Teva Investigational Site 5325
city: Bucharest
country: Romania
facility: Teva Investigational Site 5208
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 5210
city: Constanta
country: Romania
facility: Teva Investigational Site 5212
city: Targu-Mures
country: Romania
facility: Teva Investigational Site 5211
city: Timisoara
country: Romania
facility: Teva Investigational Site 5209
city: Ekaterinburg
country: Russian Federation
facility: Teva Investigational Site 5029
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5021
city: Nizhny Novgorod
country: Russian Federation
facility: Teva Investigational Site 5028
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 5027
city: Perm
country: Russian Federation
facility: Teva Investigational Site 5030
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 5022
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 5025
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 5024
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 5023
city: St.Petersburg
country: Russian Federation
facility: Teva Investigational Site 5026
city: Belgrade
country: Serbia
facility: Teva Investigational Site 6100
city: Nis
country: Serbia
facility: Teva Investigational Site 6102
city: Barcelona
country: Spain
facility: Teva Investigational Site 3132
city: Barcelona
country: Spain
facility: Teva Investigational Site 3134
city: Barcelona
country: Spain
facility: Teva Investigational Site 3144
city: Beade-Pontevedra
country: Spain
facility: Teva Investigational Site 3140
city: Getafe
country: Spain
facility: Teva Investigational Site 3142
city: Lleida
country: Spain
facility: Teva Investigational Site 3135
city: Madrid
country: Spain
facility: Teva Investigational Site 3133
city: Madrid
country: Spain
facility: Teva Investigational Site 3146
city: Murcia
country: Spain
facility: Teva Investigational Site 3137
city: Pontevedra
country: Spain
facility: Teva Investigational Site 3138
city: Salt
country: Spain
facility: Teva Investigational Site 3136
city: Santiago de Compostela
country: Spain
facility: Teva Investigational Site 3139
city: Valencia
country: Spain
facility: Teva Investigational Site 3143
city: Stockholm
country: Sweden
facility: Teva Investigational Site 4204
city: Stockholm
country: Sweden
facility: Teva Investigational Site 4205
city: Stockholm
country: Sweden
facility: Teva Investigational Site 4206
city: Izmir
country: Turkey
facility: Teva Investigational Site 8201
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 5803
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 5802
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 5804
city: Lviv
country: Ukraine
facility: Teva Investigational Site 5800
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 5801
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 3425
city: London
country: United Kingdom
facility: Teva Investigational Site 3424
city: Sheffield
country: United Kingdom
facility: Teva Investigational Site 3422
Study officials:
affiliation: U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
name: Giancarlo Comi, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: