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

Phase 3

Terminated

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Laquinimod

• Registration Number: NCT00988052
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Study Start: 2009-11-10
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Results First Submitted: 2018-11-28
• Results First Submitted QC: 2019-01-07
• Results First Posted: 2019-01-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 839

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laquinimod	Laquinimod	One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Primary Outcome Measures

Name	Time	Method
Participants With Treatment-Emergent Adverse Events (TEAEs)	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

Name	Time	Method
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study	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
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study	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)
Participants With Potentially Clinically Significant Abnormal Vital Signs	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
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study	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.

Trial Locations

Locations (135)

Teva Investigational Site 1076; 🇺🇸 Phoenix, Arizona, United States

Teva Investigational Site 1090; 🇺🇸 Centennial, Colorado, United States

Teva Investigational Site 1088; 🇺🇸 Fort Collins, Colorado, United States

Teva Investigational Site 1102; 🇺🇸 Northbrook, Illinois, United States

Teva Investigational Site 1081; 🇺🇸 Fort Wayne, Indiana, United States

Teva Investigational Site 1083; 🇺🇸 Des Moines, Iowa, United States

Teva Investigational Site 1086; 🇺🇸 Kansas City, Kansas, United States

Teva Investigational Site 1101; 🇺🇸 Lexington, Kentucky, United States

Teva Investigational Site 1096; 🇺🇸 Farmington Hills, Michigan, United States

Teva Investigational Site 1093; 🇺🇸 Minneapolis, Minnesota, United States

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