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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Multiple Sclerosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
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
Research Details
  • The study consists of 4 periods: - Screening period: up to 4 weeks, - Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS), - Extension treatment period (without placebo-control): the extension period will continue until teriflunomide is commercially available in participant's country of residence. - Post-treatment washout period: 4 weeks after last treatment intake. The maximal duration of the study period per participant is expected to be 116 weeks if he/she does not continue in the extension treatment period.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Teriflunomide, Drug : Placebo

Study Arm Groups : Teriflunomide 7 mg, Teriflunomide 14 mg, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to Conversion to Clinically Definite 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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 55 Years
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
Salford Royal NHS Foundation Trust
Salford
Manchester
M6 8HD
The Walton Centre, Neurology Department
Liverpool
L9 7LJ
Royal Victoria Infirmary
Newcastle upon Tyne
Tyne and Wear
NE1 4LP
Pfizer Investigational Site
London
E1 1BB
St George's Healthcare NHS Trust
London
SW17 0QT
Investigational Site Number 826003
Plymouth
PL6 5BX
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
EFC6260
Sponsor(s)
Sanofi
Key Dates

Recruitment Start Date

Feb 2008

Recruitment End Date

Dec 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

14 Feb 2008

Last Updated

17 Dec 2014