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Trial record 2 of 2 for:    BRAVO | Multiple Sclerosis | Italy

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

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ClinicalTrials.gov Identifier: NCT01047319
Recruitment Status : Terminated (Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose)
First Posted : January 12, 2010
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 12, 2010
Results First Submitted Date  ICMJE November 28, 2018
Results First Posted Date  ICMJE January 9, 2019
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE May 27, 2010
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 7.13 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
Safety measurement: Adverse events, vital signs, ECG findings, clinical laboratory parameters [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • Participants With Potentially Clinically Significant Abnormal Vital Signs [ Time Frame: Baseline (Day 0 for extension), Day 1 up to 7.13 years ]
    Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:
    • Pulse rate: >=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
    Note that the change is compared to baseline,
  • Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study [ Time Frame: Baseline (Day 0), Day 1 to 7.13 years ]
    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 [ Time Frame: Baseline (Day 0), Day 1 to 7.13 years ]
    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 [ Time Frame: Baseline (Day 0), Day 1 to 7.13 years ]
    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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
Tolerability: proportion of subjects (%) reason for discontinuation [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE Drug: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Study Arms  ICMJE Experimental: Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Intervention: Drug: Laquinimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
1047
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2010)
1332
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Bulgaria,   Croatia,   Czechia,   Estonia,   Georgia,   Germany,   Israel,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01047319
Other Study ID Numbers  ICMJE MS-LAQ-302E
2009-015815-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Study Sponsor  ICMJE Teva Pharmaceutical Industries, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof. Timothy Vollmer, MD University of Colorado, Denver
PRS Account Teva Pharmaceutical Industries
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP