- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487096
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.
Secondary objectives were:
- To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
- To investigate the pharmacokinetic and pharmacodynamic relationships.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The total duration of the study period per participants was 46 weeks comprising 3 periods:
- a 4-week screening period,
- a 36-week double-blind treatment period,
- a 6-week post-treatment follow-up period.
Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinically confirmed multiple sclerosis [MS];
- Expanded Disability Status Scale [EDSS] score less or equal to 6;
- Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
- Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.
Exclusion Criteria:
- Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
- Pregnant or nursing woman;
- Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
- Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
- Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Placebo (for teriflunomide),
|
film-coated tablet oral administration |
EXPERIMENTAL: Teriflunomide 7 mg
Teriflunomide 7 mg:
|
film-coated tablet oral administration
Other Names:
|
EXPERIMENTAL: Teriflunomide 14 mg
Teriflunomide 14 mg:
|
film-coated tablet oral administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)
Time Frame: 36 weeks
|
The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment. Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan. Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan. |
36 weeks
|
Overview of Adverse Events [AE]
Time Frame: from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first
|
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
|
from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI assessment: number of T1-enhancing lesions per scan
Time Frame: 36 weeks
|
T1-enhancing lesions included:
|
36 weeks
|
MRI assessment: number of T2-lesions per scan
Time Frame: 36 weeks
|
T2-lesions included:
|
36 weeks
|
MRI assessment: Number of participants with no new lesions
Time Frame: 36 weeks
|
New lesions included new T2 lesions, new enhanced T1 lesions and unique newly active lesions.
|
36 weeks
|
MRI assessment: Change from baseline in T2 burden of disease
Time Frame: 36 weeks
|
T2 burden of disease was defined as the total volume of all T2 lesions.
|
36 weeks
|
Number of participants with progression on Expanded Disability Status Scale [EDSS]
Time Frame: 36 weeks
|
EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Progression was defined as an increase in EDSS score by at least 1-point when baseline EDSS score ≤5.5 or an increase in EDSS score by at least 0.5-point in when baseline EDSS score >5.5. |
36 weeks
|
Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores.
Time Frame: 36 weeks
|
A relapse was defined as the appearance, reappearance or worsening of a symptom attributable to MS. The change had to persist for at least 48 hours in the absence of fever and be preceded by stability or improvement for at least 30 days. Relapses were to be confirmed by Scripps NRS and EDSS scores. NRS is a scale that qualifies the degree of impairment from a neurological exam of the following systems: mentation and mood, cranial nerves, motor nerves, deep tendon reflexes, sensory nerves, cerebellum, gait/trunk/balance, bladder/bowel/sexual dysfunction. NRS score ranges from 0 to 100 (lower degree of impairment). |
36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Study Director, Clinical Science & Operation - sanofi-aventis
Publications and helpful links
General Publications
- O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. doi: 10.1212/01.wnl.0000203121.04509.31.
- Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Teriflunomide
Other Study ID Numbers
- HMR1726D/2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Placebo (placebo for teriflunomide)
-
SanofiCompletedMultiple SclerosisUkraine, Russian Federation, Estonia, Czech Republic, Denmark, Finland, France, Turkey, United Kingdom, United States, Portugal, Austria, Canada, Chile, Germany, Italy, Netherlands, Norway, Poland, Sweden, Switzerland
-
SanofiActive, not recruitingRelapsing Multiple SclerosisSpain, United States, Mexico, Japan, Austria, Belarus, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, Germany, Italy, Lithuania, Poland, Romania, Russian Federation, Sweden, Taiwan, Turkey, Ukraine, Hong Kong
-
National Institute of Mental Health (NIMH)Terminated
-
SanofiActive, not recruitingRelapsing Multiple SclerosisUnited States, Argentina, Belgium, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Korea, Republic of, Latvia, Netherlands, Norway, Portugal, Puerto Rico, Russian Federation, Serbia, Slovakia, Spai... and more
-
Novartis PharmaceuticalsCompletedRelapsing Multiple ScelrosisUnited States, Austria, Belgium, Croatia, Germany, Taiwan, Canada, Czechia, Spain, Argentina, Australia, Peru, South Africa, United Kingdom, Bulgaria, Latvia, Lithuania, Russian Federation, India, Portugal, Italy, Turkey, Finland, France and more
-
Novartis PharmaceuticalsCompletedRelapsing Multiple SclerosisBelgium, Italy, United States, Croatia, Spain, Netherlands, Switzerland, Thailand, Israel, Czechia, Estonia, Poland, France, Bulgaria, Russian Federation, Germany, Turkey, Slovakia, Australia, Denmark, Greece, Argentina, India, Hungary, United Kingdom and more
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Spero TherapeuticsSimbec ResearchCompletedHealthy VolunteersUnited Kingdom
-
EnnovaBio Australia Pharmaceuticals Pty LtdNot yet recruiting
-
ZYUS Life Sciences Inc.Novotech (Australia) Pty Limited; ZYUS Life Sciences Australia Pty LtdCompletedHealthy | OsteoarthritisAustralia