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An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease

This study has been terminated.
(Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745615
First Posted: September 3, 2008
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
  Purpose

This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT2004-003943-28), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered, in subjects with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily.

Study LAQ/5063 consists of two periods:

  • The first period of the extension study is an active, double-blind period. Participants from the active treatment arms in LAQ/5062 continue their assigned treatment in blinded fashion. Participants who were assigned to placebo treatment in LAQ/5062 are equally randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg
  • Once Termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) is performed, all participants continue on laquinimod 0.6 mg daily as an open-label intervention. The open-label period continues as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS or early discontinuation.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: laquinimod 0.3 mg Drug: Laquinimod 0.6 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Blinding performed by interactive voice response system (IVRS) and relevant only to the first period of the extension. General medical evaluations will be assessed separately from neurological assessment evaluations by two different neurologists/ physicians. MRI scan evaluation will be performed at a central reading center by staff that does not have access to the clinical data.
Primary Purpose: Treatment
Official Title: An Active Extension of LAQ/5062 Study. a Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study, to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):

Primary Outcome Measures:
  • Participants with Adverse Events [ Time Frame: until study completion or termination, estimated up to 14 years ]
  • Number and percentage of subjects who prematurely discontinued from the study [ Time Frame: until study completion or termination, estimated up to 14 years ]
  • Number and percentage of subjects who prematurely discontinued from the study due to AEs [ Time Frame: until study completion or termination, estimated up to 14 years ]

Secondary Outcome Measures:
  • Relapse Rate [ Time Frame: until study completion or termination, estimated up to 14 years ]
  • The proportion of relapse free subjects [ Time Frame: until study completion or termination, estimated up to 14 years ]
  • Number of enhancing lesions on T1-weighted images [ Time Frame: week 36 ]
  • Number of new T2 lesions [ Time Frame: week 36 ]
  • Number of new hypointense T1 lesion [ Time Frame: week 36 ]
  • Change from Baseline in Kurtzke's Expanded Disability Status Scale (EDSS) Score [ Time Frame: baseline in 5062 to last EDSS reading assumed to be up to 14 years ]

Enrollment: 209
Actual Study Start Date: December 31, 2006
Study Completion Date: May 9, 2017
Primary Completion Date: May 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod 0.3 mg
Double-blind period: participants who took laquinimod 0.3 mg in the previous study, plus participants who took placebo in the previous study and were randomized to laquinimod 0.3 mg in the double-blind extension.
Drug: laquinimod 0.3 mg
Tablet formulation taken by participants in the double-blind period. Participants in the 0.3 mg treatment arm took one tablet of laquinimod 0.3mg once a day (plus a placebo tablet). Participants in the 0.6 mg treatment arm took two tables of laquinimod 0.3 mg once each day.
Other Name: TV-5600
Drug: Placebo
One tablet taken each day for participants in the laquinimod 0.3 mg treatment arm during the double-blind period.
Experimental: Laquinimod 0.6 mg

Double-blind period: Participants who took laquinimod 0.6 mg in the previous study, plus participants who took placebo in the previous study and were randomized to laquinimod 0.6 mg in the double-blind extension.

Open-label period: All study participants took laquinimod 0.6 mg once daily

Drug: laquinimod 0.3 mg
Tablet formulation taken by participants in the double-blind period. Participants in the 0.3 mg treatment arm took one tablet of laquinimod 0.3mg once a day (plus a placebo tablet). Participants in the 0.6 mg treatment arm took two tables of laquinimod 0.3 mg once each day.
Other Name: TV-5600
Drug: Laquinimod 0.6 mg
Capsule formulation taken by participants in the open-label period. Participants took one capsule each day.
Other Name: TV-5600

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • For the 36 months further extension: Subjects must have completed the 24 months of treatment of the first period of the open label phase
  • Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.)

Exclusion Criteria

  • For the 36 month further extension: Premature discontinuation from Laq/5063 OL phase prior to completion of 24 months of treatment period
  • pregnancy or breast feeding
  Contacts and Locations
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): NCT00745615


  Show 45 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Investigators
Principal Investigator: Giancarlo Comi Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy
  More Information

Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT00745615     History of Changes
Other Study ID Numbers: LAQ/5063OL
2005-004334-41 ( Registry Identifier: EUdraCT )
First Submitted: September 2, 2008
First Posted: September 3, 2008
Last Update Posted: October 11, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases