Relapsing Remitting Multiple SclerosisPhase 2NCT00745615
An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease
A Phase 2 study testing Laquinimod in people with Relapsing Remitting Multiple Sclerosis, run by Teva Pharmaceutical Industries, Ltd. at 45 sites in 9 countries.
Trial summary
This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS)… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Laquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 45 sitesin 9 countries
- Study dates
- 7 Dec 2005to 23 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria - Participants must have completed the 36 weeks of treatment (completion of the full 36 weeks or as requested by the Sponsor) of the active double-blind phase. - Women of childbearing potential (for example, women who were not postmenopausal or surgically sterilized) must have practiced 2 acceptable methods of birth control for the duration of the study and until 30 days after the last dose of study medication (acceptable methods of birth control in this open-label extension phase included intrauterine devices, barrier methods [condom or diaphragm with spermicide], and hormonal methods of birth control [for example, oral contraceptive, contraceptive patch, and long-acting injectable contraceptive]). - Participants must have been willing and able to comply with the protocol requirements for the duration of LAQ/5063 OL. - Participants must have given signed, written informed consent prior to entering LAQ/5063 OL. - For the 36 months further extension: Participants must have completed the 24 months of treatment of the first period of the open label phase. 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 breastfeeding. - Participants with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of LAQ/5063, which would have precluded safe and complete study participation. - Use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Previous treatment with immunomodulators with the exception of laquinimod (including interferon [IFN] 1a and 1b, glatiramer acetate, and intravenous [IV] immunoglobulin) within 2 months prior to entering the open-label phase for those subjects who had a time gap between termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of corticosteroids within 30 days prior to entering the open-label phase, except for IV methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of potent inhibitors of cytochrome P3A4 (CYP3A4) within 2 weeks prior to LAQ/5063 OL and/or use of fluoxetine 1 month prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of the following substrates of cytochrome P1A2 (CYP1A2): theophylline and/or warfarin within 2 weeks prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of amiodarone in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Following the switch to new formulation (capsules), hypersensitivity to mannitol, meglumine, or sodium stearyl fumarate.
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
Russia9 sites
Teva Investigational Site 186
Moscow
Teva Investigational Site 187
Moscow
Teva Investigational Site 188
Moscow
Teva Investigational Site 189
Moscow
Teva Investigational Site 180
Saint Petersburg
Teva Investigational Site 181
Saint Petersburg
Teva Investigational Site 182
Saint Petersburg
Teva Investigational Site 184
Saint Petersburg
Teva Investigational Site 185
Saint Petersburg
Germany6 sites
Teva Investigational Site 681
Berlin
Teva Investigational Site 684
Erfurt
Teva Investigational Site 687
Hamburg
Teva Investigational Site 683
Mainz
Teva Investigational Site 686
Ulm
Teva Investigational Site 685
Würzburg
Poland6 sites
Teva Investigational Site 281
Bydgoszcz
Teva Investigational Site 280
Katowice
Teva Investigational Site 285
Katowice
Teva Investigational Site 283
Lodz
Teva Investigational Site 284
Lublin
Teva Investigational Site 282
Wroclaw
Spain6 sites
Teva Investigational Site 782
Barakaldo
Teva Investigational Site 785
Barcelona
Teva Investigational Site 781
Bilbao
Teva Investigational Site 784
L'Hospitalet de Llobregat
Teva Investigational Site 780
Madrid
Teva Investigational Site 783
Seville
Hungary4 sites
Teva Investigational Site 580
Debrecen
Teva Investigational Site 581
Gyula
Teva Investigational Site 583
Miskolc
Teva Investigational Site 584
Veszprém
Italy4 sites
Teva Investigational Site 483
Cagliari
Teva Investigational Site 484
Milan
Teva Investigational Site 486
Milan
Teva Investigational Site 488
Siena
United Kingdom4 sites
Teva Investigational Site 884
Liverpool
Teva Investigational Site 882
London
Teva Investigational Site 881
Sheffield
Teva Investigational Site 883
Stoke-on-Trent
Czechia3 sites
Teva Investigational Site 382
Hradec Králové
Teva Investigational Site 380
Prague
Teva Investigational Site 384
Praha 5- Motol
Israel3 sites
Teva Investigational Site 982
Haifa
Teva Investigational Site 980
Jerusalem
Teva Investigational Site 981
Ramat Gan, IL
About this study
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)
This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily. This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063 OL (i.e., subsequent open-label extension). - 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Laquinimod, Placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaquinimodDrug
Also called TV-5600
Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
PlaceboDrug
Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind: Laquinimod 0.3 mg | Experimental | Participants who will be receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, will continue to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Receives: Drug: Laquinimod |
| Double-Blind: Laquinimod 0.6 mg | Experimental | Participants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, will continue to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Receives: Drug: Laquinimod |
| Double-Blind: Placebo/Laquinimod 0.3 mg | Experimental | Participants who will be receiving placebo matching to laquinimod 0.3 mg tablet once daily orally in double-blind core study, will receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Receives: Drug: Laquinimod; Drug: Placebo |
| Double-Blind: Placebo/Laquinimod 0.6 mg | Experimental | Participants who will be receiving placebo matching to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, will receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Receives: Drug: Laquinimod; Drug: Placebo |
| Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg | Experimental | Participants who will be receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). Receives: Drug: Laquinimod |
| Open Label: Laquinimod 0.6 mg | Experimental | Participants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). Receives: Drug: Laquinimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double-Blind Extension Period: Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Measured: Baseline (Week 0) to Week 36
Open-label Extension Period: Number of Participants With AEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Measured: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)
Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Measured: Baseline (Week 0) to Week 36
Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Measured: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)
Secondary outcomes (7)
Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses
Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the Expanded disability status scale (EDSS); or one grade in the score of 2 or more of the 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).
Measured: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Percentage of Relapse-Free Participants
Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the EDSS; or one grade in the score of 2 or more of the 7 FS (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS).
Measured: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions. T1-weighted scan was taken after administration of gadolinium-gadopentetic acid (Gd-DTPA).
Measured: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of New T2 Lesions
Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions.
Measured: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Volume of T2 Lesions
Volume of T2 lesion was assessed by magnetic MRI.
Measured: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans
Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions.
Measured: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score
EDSS (developed by John F. Kurtzke) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and other functions). Each functional system score and an overall score ranges from 0 to 10, where 0 = Normal; 1-1.5 = No disability, but some abnormal neurological signs; 2-2.5 = Minimal disability; 3-4.5 = Moderate disability, affecting daily activities, but can still walk; 5-8 = More severe disability, impairing daily activities and requiring assistance with walking; 8.5-9.5 = Very severe disability, restricting to bed; 10 = Death due to MS. A lower score indicated less disability.
Measured: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study start7 Dec 2005
- Primary completion23 Jul 2017
- Study completion23 Jul 2017
Why it stopped: Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giancarlo Comi, Principal investigator, Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745615
- Sponsor's protocol ID
- LAQ/5063OL
- Other IDs
- LAQ/5063, 2005-004334-41, 2005
- Status last verified
- Mar 2019
- First submitted
- 2 Sep 2008
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00745615
- Acronym / sponsor ID
- LAQ/5063OL
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2005 (actual)
- Primary completion
- 23 Jul 2017 (actual)
- Study completion
- 23 Jul 2017 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 27 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily. This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063 OL (i.e., subsequent open-label extension). - 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Double-Blind: Laquinimod 0.3 mg | Experimental | Drug: LaquinimodParticipants who will be receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, will continue to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. |
| Double-Blind: Laquinimod 0.6 mg | Experimental | Drug: LaquinimodParticipants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, will continue to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. |
| Double-Blind: Placebo/Laquinimod 0.3 mg | Experimental | Drug: Laquinimod, Drug: PlaceboParticipants who will be receiving placebo matching to laquinimod 0.3 mg tablet once daily orally in double-blind core study, will receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. |
| Double-Blind: Placebo/Laquinimod 0.6 mg | Experimental | Drug: Laquinimod, Drug: PlaceboParticipants who will be receiving placebo matching to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, will receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. |
| Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg | Experimental | Drug: LaquinimodParticipants who will be receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). |
| Open Label: Laquinimod 0.6 mg | Experimental | Drug: LaquinimodParticipants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaquinimodAlso: TV-5600Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms. | Drug | Double-Blind: Laquinimod 0.3 mg, Double-Blind: Laquinimod 0.6 mg, Double-Blind: Placebo/Laquinimod 0.3 mg, Double-Blind: Placebo/Laquinimod 0.6 mg, Open Label: Laquinimod 0.6 mg, Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg |
| PlaceboPlacebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms. | Drug | Double-Blind: Placebo/Laquinimod 0.3 mg, Double-Blind: Placebo/Laquinimod 0.6 mg |
Primary outcome
Double-Blind Extension Period: Number of Participants With Adverse Events (AEs)
Time frame: Baseline (Week 0) to Week 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Open-label Extension Period: Number of Participants With AEs
Time frame: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Time frame: Baseline (Week 0) to Week 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Time frame: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
7 secondary outcomes
Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses
Time frame: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Percentage of Relapse-Free Participants
Time frame: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images
Time frame: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of New T2 Lesions
Time frame: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Volume of T2 Lesions
Time frame: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans
Time frame: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score
Time frame: At the end of active double-blind phase or termination/early termination visit (up to Week 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Comi principal investigator
Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laquinimod in people with Relapsing Remitting Multiple Sclerosis, run by Teva Pharmaceutical Industries, Ltd. at 45 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Russia, Germany, Poland, Spain, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) (time frame: Baseline (Week 0) to Week 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.