Clinical trial NCT01047319: A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
Official title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, 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
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: 2010-01-12
Enrollment: 1047
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 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-302 (completion of all Termination visit activities) according to the MS-LAQ-302 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-302E study.

Exclusion Criteria:

1. Premature discontinuation from the MS-LAQ-302 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-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E 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 7.13 years
Secondary outcomes:
measure: Participants With Potentially Clinically Significant Abnormal Vital Signs
timeFrame: Baseline (Day 0 for extension), Day 1 up to 7.13 years
measure: Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
timeFrame: Baseline (Day 0), Day 1 to 7.13 years
measure: Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
timeFrame: Baseline (Day 0), Day 1 to 7.13 years
measure: Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
timeFrame: Baseline (Day 0), Day 1 to 7.13 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Teva Investigational Site 1267
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 1237
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 1279
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 1276
state: Arizona
city: Pasadena
country: United States
facility: Teva Investigational Site 1272
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 1238
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 1280
state: Colorado
city: Sarasota
country: United States
facility: Teva Investigational Site 1282
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 1275
state: Georgia
city: Peoria
country: United States
facility: Teva Investigational Site 1250
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 1260
state: Indiana
city: Shreveport
country: United States
facility: Teva Investigational Site 1263
state: Louisiana
city: Baltimore
country: United States
facility: Teva Investigational Site 1269
state: Maryland
city: Albany
country: United States
facility: Teva Investigational Site 1273
state: New York
city: Amherst
country: United States
facility: Teva Investigational Site 1264
state: New York
city: Akron
country: United States
facility: Teva Investigational Site 1261
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 1245
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 1247
state: Ohio
city: Portland
country: United States
facility: Teva Investigational Site 1244
state: Oregon
city: Nashville
country: United States
facility: Teva Investigational Site 1281
state: Tennessee
city: Roanoke
country: United States
facility: Teva Investigational Site 1270
state: Virginia
city: Tacoma
country: United States
facility: Teva Investigational Site 1253
state: Washington
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 5914
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 5915
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 5917
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 4212
city: Shumen
country: Bulgaria
facility: Teva Investigational Site 5916
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5920
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5907
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5910
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5909
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5919
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5906
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5908
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5911
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 5912
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 5918
city: Varna
country: Bulgaria
facility: Teva Investigational Site 5913
city: Veliko Tarnovo
country: Bulgaria
facility: Teva Investigational Site 4211
city: Osijek
country: Croatia
facility: Teva Investigational Site 6003
city: Varazdin
country: Croatia
facility: Teva Investigational Site 6005
city: Zagreb
country: Croatia
facility: Teva Investigational Site 6001
city: Zagreb
country: Croatia
facility: Teva Investigational Site 6002
city: Zagreb
country: Croatia
facility: Teva Investigational Site 6006
city: Olomouc
country: Czechia
facility: Teva Investigational Site 5419
city: Praha 2
country: Czechia
facility: Teva Investigational Site 5418
city: Praha 5- Motol
country: Czechia
facility: Teva Investigational Site 5420
city: Teplice
country: Czechia
facility: Teva Investigational Site 5421
city: Kohtla-Jarve
country: Estonia
facility: Teva Investigational Site 5508
city: Tallinn
country: Estonia
facility: Teva Investigational Site 5507
city: Tartu
country: Estonia
facility: Teva Investigational Site 5509
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 8102
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 8104
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 8103
city: Berlin
country: Germany
facility: Teva Investigational Site 6703
city: Berlin
country: Germany
facility: Teva Investigational Site 6402
city: Ulm
country: Germany
facility: Teva Investigational Site 6400
city: Jerusalem
country: Israel
facility: Teva Investigational Site 8041
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 8040
city: Bologna
country: Italy
facility: Teva Investigational Site 3056
city: Cefalu
country: Italy
facility: Teva Investigational Site 3053
city: Chieti
country: Italy
facility: Teva Investigational Site 3054
city: Empoli
country: Italy
facility: Teva Investigational Site 3061
city: Firenze
country: Italy
facility: Teva Investigational Site 3049
city: Napoli
country: Italy
facility: Teva Investigational Site 3055
city: Rome
country: Italy
facility: Teva Investigational Site 3048
city: Rome
country: Italy
facility: Teva Investigational Site 3052
city: Rome
country: Italy
facility: Teva Investigational Site 3050
city: Kaunas
country: Lithuania
facility: Teva Investigational Site 5708
city: Siauliai
country: Lithuania
facility: Teva Investigational Site 5707
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 6500
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 6501
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 6502
city: Bialystok
country: Poland
facility: Teva Investigational Site 5337
city: Gdansk
country: Poland
facility: Teva Investigational Site 5329
city: Gdansk
country: Poland
facility: Teva Investigational Site 5338
city: Gorzow Wielkopolski
country: Poland
facility: Teva Investigational Site 6602
city: Grodzisk Mazowiecki
country: Poland
facility: Teva Investigational Site 5333
city: Katowice
country: Poland
facility: Teva Investigational Site 5334
city: Katowice
country: Poland
facility: Teva Investigational Site 5339
city: Kielce
country: Poland
facility: Teva Investigational Site 6603
city: Konskie
country: Poland
facility: Teva Investigational Site 4213
city: Koscierzyna
country: Poland
facility: Teva Investigational Site 5332
city: Krakow
country: Poland
facility: Teva Investigational Site 5345
city: Lodz
country: Poland
facility: Teva Investigational Site 5328
city: Olsztyn
country: Poland
facility: Teva Investigational Site 5330
city: Szczecin
country: Poland
facility: Teva Investigational Site 5331
city: Warsaw
country: Poland
facility: Teva Investigational Site 5336
city: Warszawa
country: Poland
facility: Teva Investigational Site 5340
city: Warszawa
country: Poland
facility: Teva Investigational Site 5341
city: Wroclaw
country: Poland
facility: Teva Investigational Site 5335
city: Balotesti
country: Romania
facility: Teva Investigational Site 5235
city: Bucharest
country: Romania
facility: Teva Investigational Site 5218
city: Bucuresti
country: Romania
facility: Teva Investigational Site 5214
city: Bucuresti
country: Romania
facility: Teva Investigational Site 5213
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 5215
city: Constanta
country: Romania
facility: Teva Investigational Site 5217
city: Craiova
country: Romania
facility: Teva Investigational Site 8209
city: Iasi
country: Romania
facility: Teva Investigational Site 5216
city: Sibiu
country: Romania
facility: Teva Investigational Site 5219
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 5043
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5033
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5041
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5032
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 5038
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 5042
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 5035
city: Samara
country: Russian Federation
facility: Teva Investigational Site 5037
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 5036
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 5034
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 5044
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 6200
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 6201
city: Nitra
country: Slovakia
facility: Teva Investigational Site 6202
city: Zilina
country: Slovakia
facility: Teva Investigational Site 6203
city: Bloemfontein
country: South Africa
facility: Teva Investigational Site 9007
city: Cape Town
country: South Africa
facility: Teva Investigational Site 9001
city: Johannesburg
country: South Africa
facility: Teva Investigational Site 9004
city: Parktown- Johannesburg
country: South Africa
facility: Teva Investigational Site 9003
city: Pietermaritzburg
country: South Africa
facility: Teva Investigational Site 9008
city: Pretoria
country: South Africa
facility: Teva Investigational Site 9005
city: Rosebank
country: South Africa
facility: Teva Investigational Site 9006
city: Barcelona
country: Spain
facility: Teva Investigational Site 3147
city: Figueres-Girona
country: Spain
facility: Teva Investigational Site 3154
city: L'Hospitalet de Llobregat
country: Spain
facility: Teva Investigational Site 3149
city: Madrid
country: Spain
facility: Teva Investigational Site 3152
city: Malaga
country: Spain
facility: Teva Investigational Site 3151
city: Sevilla
country: Spain
facility: Teva Investigational Site 3148
city: Tortosa-Tarragona
country: Spain
facility: Teva Investigational Site 3153
city: Chernihiv
country: Ukraine
facility: Teva Investigational Site 6503
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 5823
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 5811
city: Donetsk
country: Ukraine
facility: Teva Investigational Site 5812
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 5814
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 5817
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 5818
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 5815
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 5822
city: Lviv
country: Ukraine
facility: Teva Investigational Site 5809
city: Odessa
country: Ukraine
facility: Teva Investigational Site 5820
city: Poltava
country: Ukraine
facility: Teva Investigational Site 5821
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 5810
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 5819
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 5816
Study officials:
affiliation: University of Colorado, Denver
name: Prof. Timothy Vollmer, MD
role: PRINCIPAL_INVESTIGATOR
References: