Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis | Not Recruiting
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
TOPIC
Trial Source

Health Conditions
  • Multiple Sclerosis
Not Recruiting
Recruitment Status
NCT00622700
Primary Trial ID Number
Summary
The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
Primary Outcome Measures
  • Time to Conversion to Clinically Deļ¬nite Multiple Sclerosis (CDMS); Up to a maximum of 108 weeks depending on time of enrollment
Secondary Outcome Measures
  • Time to Conversion to Definite Multiple Sclerosis (DMS); Up to a maximum of 108 weeks depending on time of enrollment; Annualized Relapse Rate (ARR); Up to a maximum of 108 weeks depending on time of enrollment; Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108; Baseline, Week 108; Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates); Up to a maximum of 108 weeks depending on time of enrollment; Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan; Up to a maximum of 108 weeks depending on time of enrollment; Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component; Baseline, Week 108; Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component; Baseline, Week 108; Brain MRI Assessment: Percent Change From Baseline in Atrophy; Baseline, Week 108; Time to 12-Week Sustained Disability Progression; Up to a maximum of 108 weeks depending on time of enrollment; Change From Baseline in EDSS at Week 108; Baseline, Week 108; Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108; Baseline, Week 108; Overview of Adverse Events (AEs); From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
Research Question
  • The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Australia; Austria; Bulgaria; Canada; Chile; Czech Republic; Denmark; Estonia; Finland; France; Germany; Hungary; Lithuania; Mexico; Poland; Romania; Russian Federation; Turkey; Ukraine; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 55 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - First acute or subacute, well-defined neurological event consistent with
  • demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord
  • syndrome, brainstem/cerebellar syndromes)
  • - Onset of MS symptoms occurring within 90 days of randomization
  • - A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter
  • that are characteristic of MS
  • Exclusion Criteria:
  • - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
  • systemic disease
  • - Significantly impaired bone marrow function
  • - Pregnancy or nursing
  • - Alcohol or drug abuse
  • - 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
  • participant's potential participation in a clinical trial.
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - First acute or subacute, well-defined neurological event consistent with
  • demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord
  • syndrome, brainstem/cerebellar syndromes)
  • - Onset of MS symptoms occurring within 90 days of randomization
  • - A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter
  • that are characteristic of MS
  • Exclusion Criteria:
  • - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
  • systemic disease
  • - Significantly impaired bone marrow function
  • - Pregnancy or nursing
  • - Alcohol or drug abuse
  • - 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
  • participant's potential participation in a clinical trial.
Interventions
Drug; Teriflunomide; Film-coated tablet Oral administration; [Teriflunomide 7 mg, Teriflunomide 14 mg]; Drug; Placebo; Film-coated tablet Oral administration; [Placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
TOPIC
Scientific Title
An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period
Secondary Trial Identifying Number
HMR1726D-3005; 2006-001152-12
Website
Sorry, this information is not available
Study Funded By
Sanofi
Funder Type
Sorry, this information is not available
Study Sponsored By
Sanofi
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 Feb 2008

Last Updated

17 Dec 2014

Date Record Refreshed on UKCTG

31 Jul 2015