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

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ClinicalTrials.gov Identifier: NCT00988052
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 : October 1, 2009
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

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.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Laquinimod Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 10, 2009
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Drug: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.




Primary Outcome Measures :
  1. Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 7.64 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.


Secondary Outcome Measures :
  1. Participants With Potentially Clinically Significant Abnormal Vital Signs [ Time Frame: Day 1 up to 7.64 years ]

    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

  2. Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study [ Time Frame: Day 1 up to 7.64 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

  3. Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study [ Time Frame: Day 1 up to 7.64 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.

  4. Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study [ Time Frame: Day 1 up to 7.64 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988052


  Show 135 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Investigators
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Principal Investigator: Giancarlo Comi, Prof., MD U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
  Study Documents (Full-Text)

Documents provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):

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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT00988052     History of Changes
Other Study ID Numbers: MS-LAQ-301E
2009-012989-30 ( EudraCT Number )
First Posted: October 1, 2009    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):
Relapsing Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Disease Progression
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes