Phase III Study With Teriflunomide Versus Placebo in Patients With First Cl... | Completed
Phase III Study With Teriflunomide ... | Completed
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
TOPIC
Trial Source

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Medical Conditions
  • Multiple Sclerosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00622700
Primary Trial ID Number

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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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
E1 1BB
GSK Investigational Site
Sheffield
S10 2JF
St. George's Hospital
London
England
SW17 0QT
Nottingham
NG7 2UH
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Liverpool
L9 7LJ
Investigational Site Number 8708
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
Australia, Austria, Bulgaria, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Lithuania, Mexico, Poland, Romania, Russian Federation, Turkey, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

14 Feb 2008

Date updated in source

25 Feb 2016