Relapsing Multiple SclerosisPhase 2NCT01404117
A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability
A Phase 2 study testing Laquinimod 0.6 and Laquinimod 1.2 in people with Relapsing Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Laquinimod 0.6 and Laquinimod 1.2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have a documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2011: 69:292-302], with a relapsing-remitting disease course.
- Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit.
- Subjects must be relapse-free and in a stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or oral] 30 days prior to screening (month -1).
- Subjects must be treated with either Copaxone® or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®), at a stable dose for at least 6 months prior to the screening visit (switching between IFN-B preparations during the 6 months prior to screening is allowed; switching between any IFN-B preparation and GA, or vice versa, is exclusionary).
- Subjects must have had experienced at least one documented relapse in the 36 weeks prior to randomization, with an incomplete recovery of the neurological functions as compared to pre-relapse status.
- Subjects must be between 18 and 55 years of age, inclusive.
Show all 9Show fewer
- Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barrier method (condom or diaphragm with spermicide)].
- Subjects must be able to sign and date a written informed consent prior to entering the study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Who cannot join
- An onset of a relapse between Month -1 (Screening) and 0 (Baseline), unstable neurological condition or any treatment with corticosteroids [intravenous (IV), intramuscular (IM) and/or oral] or Adrenocorticotropic hormone.
- Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to Screening.
- Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
- Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod, and fingolimod (Gilenya®).
- Previous treatment with intravenous immunoglobulin (IVIG) within 2 months prior to screening visit.
- Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
Show all 30Show fewer
- Previous total body irradiation or total lymphoid irradiation.
- Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
- Use of moderate/strong inhibitors of cytochrome P450 CYP3A4 within 2 weeks prior to the screening visit.
- Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.
- Use of amiodarone within 2 years prior to screening visit.
- Pregnancy or breastfeeding.
- A ≥3xULN serum elevation of either alanine transaminase (ALT) or aspartate transaminase (AST) at screening.
- Serum direct bilirubin which is ≥2x upper limit of normal (ULN) at screening.
- Subjects with a potentially clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include (but are not limited to):
- A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
- A gastrointestinal disorder that may affect the absorption of study medication.
- Renal or metabolic diseases
- Any form of acute or chronic liver disease
- Known human immunodeficiency virus (HIV) positive status
- A history of drug and/or alcohol abuse
- An unstable psychiatric disorder.
- A known history of tuberculosis.
- Unstable psychiatric disorder
- Any malignancies, excluding basal cell carcinoma (BCC), in the last 5 years.
- A glomerular filtration rate less than 60 ml/min at screening visit.
- A known history of sensitivity to gadolinium (Gd).
- Inability to successfully undergo MRI scanning.
- Previous endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
- Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
About this study
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS) subjects
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Laquinimod 0.6, Laquinimod 1.2, Glatiramer Acetate or interferon-beta+ Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laquinimod 0.6Drug
Laquinimod 0.6 capsule
Laquinimod 1.2Drug
Placebo
Glatiramer Acetate or interferon-beta+ PlaceboOther
GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo
| Study group | Role | What they receive |
|---|---|---|
| Laquinimod 0.6 | Experimental | GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg Receives: Drug: Laquinimod 0.6 |
| Laquinimod 1.2 | Experimental | GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 1.2 mg Receives: Drug: Laquinimod 1.2 |
| GA or IFN + Placebo | Experimental | GA 20 mg/1mL or an IFN-B preparation + oral daily placebo Receives: Other: Glatiramer Acetate or interferon-beta+ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
To assess the safety, tolerability and efficacy of laquinimod in RRMS
Measured: 10 months
Secondary outcomes (1)
Tolerability
To assess the safety, tolerability and efficacy of laquinimod in RRMS as compared to placebo, subjects treated with GA or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Why it stopped: Study is being redesigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Gold, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404117
- Sponsor's protocol ID
- LAQ-MS-201
- Status last verified
- Aug 2013
- First submitted
- 26 Jul 2011
- Last updated
- 27 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability
- ClinicalTrials.gov ID
- NCT01404117
- Acronym / sponsor ID
- LAQ-MS-201
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is being redesigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 27 Jul 2011 (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.
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS) subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laquinimod 0.6 | Experimental | Drug: Laquinimod 0.6GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg |
| Laquinimod 1.2 | Experimental | Drug: Laquinimod 1.2GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 1.2 mg |
| GA or IFN + Placebo | Experimental | Other: Glatiramer Acetate or interferon-beta+ PlaceboGA 20 mg/1mL or an IFN-B preparation + oral daily placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must have a documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2011: 69:292-302], with a relapsing-remitting disease course.
- Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit.
- Subjects must be relapse-free and in a stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or oral] 30 days prior to screening (month -1).
- Subjects must be treated with either Copaxone® or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®), at a stable dose for at least 6 months prior to the screening visit (switching between IFN-B preparations during the 6 months prior to screening is allowed; switching between any IFN-B preparation and GA, or vice versa, is exclusionary).
- Subjects must have had experienced at least one documented relapse in the 36 weeks prior to randomization, with an incomplete recovery of the neurological functions as compared to pre-relapse status.
Key exclusion criteria (30 listed)
- An onset of a relapse between Month -1 (Screening) and 0 (Baseline), unstable neurological condition or any treatment with corticosteroids [intravenous (IV), intramuscular (IM) and/or oral] or Adrenocorticotropic hormone.
- Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to Screening.
- Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
- Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod, and fingolimod (Gilenya®).
- Previous treatment with intravenous immunoglobulin (IVIG) within 2 months prior to screening visit.
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 0.6Laquinimod 0.6 capsule | Drug | Laquinimod 0.6 |
| Laquinimod 1.2Placebo | Drug | Laquinimod 1.2 |
| Glatiramer Acetate or interferon-beta+ PlaceboGA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo | Other | GA or IFN + Placebo |
Primary outcome
Safety and efficacy
Time frame: 10 months
To assess the safety, tolerability and efficacy of laquinimod in RRMS
1 secondary outcome
Tolerability
Time frame: 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
Related trials for Relapsing Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingPhase 2/3
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Relapsing 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.
Ralf Gold, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laquinimod 0.6 and Laquinimod 1.2 in people with Relapsing 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 9 inclusion and 30 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: withdrawn, as of the sponsor's last update on 27 Aug 2013. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and efficacy (time frame: 10 months). 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 Aug 2013.