Relapsing Remitting Multiple SclerosisPhase 2NCT00349193
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
A Phase 2 study testing laquinimod 0.3 and laquinimod 0.6 in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions. The duration of the current study is 36 weeks. 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 0.3 and laquinimod 0.6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Willing and able to give written informed consent
- Confirmed MS diagnosis as defined by the McDonald criteria
- R-R MS disease course.
- At least one gadolinium-enhanced lesion on screening MRI
- Women of child-bearing potential must practice a reliable method of birth control.
- Must understand the requirements of the study and agree to comply with the study protocol.
Who cannot join
- Subjects who suffer from any form of progressive MS.
- Any condition which the investigator feels may interfere with participation in the study.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
- Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
- Previous treatment with immunomodulators within two months prior to screening
About this study
Official title: A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects
Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.
The duration of the current study is 36 weeks.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- laquinimod 0.3, laquinimod 0.6, Placebo
- Keywords
- Relapsing Remitting Multiple Sclerosis
- 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.
laquinimod 0.3Drug
laquinimod 0.3mg
laquinimod 0.6Drug
laquinimod 0.6mg
PlaceboOther
Blinded Placebo
| Study group | Role | What they receive |
|---|---|---|
| Laquinimod 0.3 mg | Active comparator | Laquinimod 0.3 mg Receives: Drug: laquinimod 0.3 |
| Laquinimod 0.6 mg | Active comparator | Laquinimod 0.6 mg Receives: Drug: laquinimod 0.6 |
| Placebo | Placebo comparator | Blinded Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of brain lesions in the last 4 months of the study
Measured: 36 weeks
Secondary outcomes (1)
Relapse rate
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Giancarlo Comi, Study chair, Teva Pharmaceutical Industries, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349193
- Sponsor's protocol ID
- LAQ/5062
- Other IDs
- 2004-003943-28, 2004
- Status last verified
- Apr 2011
- First submitted
- 26 Jun 2006
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Comi G, Pulizzi A, Rovaris M, Abramsky O, Arbizu T, Boiko A, Gold R, Havrdova E, Komoly S, Selmaj K, Sharrack B, Filippi M; LAQ/5062 Study Group. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Jun 21;371(9630):2085-92. doi: 10.1016/S0140-6736(08)60918-6.
PubMed 18572078
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects
- ClinicalTrials.gov ID
- NCT00349193
- Acronym / sponsor ID
- LAQ/5062
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.
The duration of the current study is 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laquinimod 0.3 mg | Active comparator | Drug: laquinimod 0.3Laquinimod 0.3 mg |
| Laquinimod 0.6 mg | Active comparator | Drug: laquinimod 0.6Laquinimod 0.6 mg |
| Placebo | Placebo comparator | Other: PlaceboBlinded Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to give written informed consent
- Confirmed MS diagnosis as defined by the McDonald criteria
- R-R MS disease course.
- At least one gadolinium-enhanced lesion on screening MRI
- Women of child-bearing potential must practice a reliable method of birth control.
Key exclusion criteria (5 listed)
- Subjects who suffer from any form of progressive MS.
- Any condition which the investigator feels may interfere with participation in the study.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
- Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
- Previous treatment with immunomodulators within two months prior to screening
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 |
|---|---|---|
| laquinimod 0.3laquinimod 0.3mg | Drug | Laquinimod 0.3 mg |
| laquinimod 0.6laquinimod 0.6mg | Drug | Laquinimod 0.6 mg |
| PlaceboBlinded Placebo | Other | Placebo |
Primary outcome
Reduction of brain lesions in the last 4 months of the study
Time frame: 36 weeks
1 secondary outcome
Relapse rate
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
- Derived from this study: PubMed 18572078Comi G, Pulizzi A, Rovaris M, Abramsky O, Arbizu T, Boiko A, Gold R, Havrdova E, Komoly S, Selmaj K, Sharrack B, Filippi M; LAQ/5062 Study Group. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Jun 21;371(9630):2085-92. doi: 10.1016/S0140-6736(08)60918-6.
Related trials for Relapsing Remitting Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
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.
Prof. Giancarlo Comi study chair
Teva Pharmaceutical Industries, Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laquinimod 0.3 and laquinimod 0.6 in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of brain lesions in the last 4 months of the study (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00349193, which also lists 1 linked publication.
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 8 Apr 2011.