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Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00622700
First received: February 14, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The primary objective is to demonstrate that early intervention with Teriflunomide in patients presenting with their first clinical episode consistent with MS prevents or delays conversion to clinically definite Multiple Sclerosis [MS].

The secondary objectives are:

  • to demonstrate that Teriflunomide prevents or delays conversion to MS based on the revised McDonald Criteria and delays disability progression,
  • to evaluate the long-term safety of Teriflunomide,

in this population.


Condition Intervention Phase
Multiple Sclerosis
Drug: Teriflunomide
Drug: Placebo (for teriflunomide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Conversion to clinically definite MS as defined by the occurrence of a relapse [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conversion to definite MS as demonstrated by the dissemination of cerebral Magnetic Resonance Imaging (MRI) lesions in time (revised McDonald criteria 2005) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Annualized relapse rate (number of relapses per subject/year) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Burden of disease [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the volume of abnormal brain tissue as assessed by cerebral MRI

  • Disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Patient reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Enrollment: 618
Study Start Date: February 2008
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriflunomide 7 mg Drug: Teriflunomide
Tablet, oral administration once daily
Other Names:
  • HMR1726
  • Aubagio
Experimental: Teriflunomide 14 mg Drug: Teriflunomide
Tablet, oral administration once daily
Other Names:
  • HMR1726
  • Aubagio
Placebo Comparator: Placebo Drug: Placebo (for teriflunomide)
Matching tablet, oral administration once daily

Detailed Description:

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 patients who experienced conversion to clinical definite MS),
  • Extension treatment period (without placebo-control): the extension period will continue until teriflunomide is commercially available in patient's country of residence.
  • Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per patient is expected to be 116 weeks if he/she does not continue in the extension treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First acute or subacute, well-defined neurological event consistent with demyelination (i.e. 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 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 patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622700

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 8965
Cullman, Alabama, United States, 35058
United States, Arizona
Investigational Site Number 8946
Phoenix, Arizona, United States, 85060
Investigational Site Number 8954
Phoenix, Arizona, United States, 85013-4496
United States, Colorado
Investigational Site Number 8962
Fort Collins, Colorado, United States, 80528
United States, Florida
Investigational Site Number 8920
Maitland, Florida, United States, 32761
Investigational Site Number 8953
St. Petersburg, Florida, United States, 33701
United States, Indiana
Investigational Site Number 8914
Ft. Wayne, Indiana, United States, 63104
Investigational Site Number 8940
Indianapolis, Indiana, United States, 46256
United States, Louisiana
Investigational Site Number 8922
Shreveport, Louisiana, United States, 71103
United States, Michigan
Investigational Site Number 8955
Grand Rapids, Michigan, United States, 49503
Investigational Site Number 8949
Traverse City, Michigan, United States, 49684
United States, Missouri
Investigational Site Number 8937
St Louis, Missouri, United States, 63104
United States, New Mexico
Investigational Site Number 8951
Albuquerque, New Mexico, United States, 87131
United States, New York
Investigational Site Number 8925
New York, New York, United States, 10029-6574
United States, North Carolina
Investigational Site Number 8941
Charlotte, North Carolina, United States, 28204
United States, Ohio
Investigational Site Number 8924
Dayton, Ohio, United States, 45409
United States, Tennessee
Investigational Site Number 8905
Round Rock, Tennessee, United States, 78681
United States, Vermont
Investigational Site Number 8930
Burlington, Vermont, United States, 05401
United States, Washington
Investigational Site Number 8963
Seattle, Washington, United States, 98122
Australia
Investigational Site Number 1405
Geelong, Australia, 3220
Investigational Site Number 1404
Heidelberg, Australia, 3081
Investigational Site Number 1407
Hobart, Australia, 7001
Investigational Site Number 1401
Parkville, Australia, 3050
Austria
Investigational Site Number 4004
Innsbruck, Austria, 6020
Investigational Site Number 4005
Linz, Austria, 4020
Investigational Site Number 4001
Wien, Austria, 1010
Bulgaria
Investigational Site Number 5312
Pleven, Bulgaria, 5800
Investigational Site Number 5309
Sofia, Bulgaria, 1431
Investigational Site Number 5303
Sofia, Bulgaria, 1527
Investigational Site Number 5304
Sofia, Bulgaria, 1407
Investigational Site Number 5306
Sofia, Bulgaria, 1606
Investigational Site Number 5307
Sofia, Bulgaria, 1000
Canada
Investigational Site Number 5402
Greenfield Park, Canada, J4V 2J2
Investigational Site Number 5403
London, Canada, N6A 5A5
Investigational Site Number 5409
Montreal, Canada, H1T 2M4
Investigational Site Number 5401
Ottawa, Canada, K1H 8L6
Investigational Site Number 5406
Quebec, Canada, G1J 1Z4
Investigational Site Number 5408
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 5404
Toronto, Canada, M5B 1W8
Investigational Site Number 5410
Toronto, Canada, M4N 3M5
Chile
Investigational Site Number 5602
Santiago, Chile, 760-0746
Investigational Site Number 5606
Santiago, Chile
Investigational Site Number 5601
Santiago, Chile
Investigational Site Number 5605
Viña Del Mar, Chile, 2520997
Czech Republic
Investigational Site Number 5801
Brno, Czech Republic, 65691
Investigational Site Number 5803
Hradec Kralove, Czech Republic, 50005
Investigational Site Number 5804
Olomouc, Czech Republic, 77520
Investigational Site Number 5805
Ostrava - Poruba, Czech Republic, 70852
Denmark
Investigational Site Number 6002
Aarhus C, Denmark, 8000
Investigational Site Number 6004
Esbjerg, Denmark, 6700
Estonia
Investigational Site Number 6201
Tallinn, Estonia, 10617
Investigational Site Number 6203
Tartu, Estonia, 50406
Finland
Investigational Site Number 6405
Helsinki, Finland, 00100
Investigational Site Number 6403
Kuopio, Finland, 70210
Investigational Site Number 6401
Turku, Finland, 20100
France
Investigational Site Number 6611
Besancon, France, 25030
Investigational Site Number 6601
Clermont Ferrand Cedex 1, France, 63003
Investigational Site Number 6609
Lille Cedex, France, 59037
Investigational Site Number 6604
Montpellier Cedex 05, France, 34295
Investigational Site Number 6612
Nancy Cedex, France, 54036
Investigational Site Number 6605
Nantes Cedex 01, France, 44093
Investigational Site Number 6602
Nice Cedex, France, 06002
Investigational Site Number 6614
Nimes, France, 30029
Investigational Site Number 6607
Strasbourg Cedex, France, 67091
Germany
Investigational Site Number 6801
Bayreuth, Germany, 95445
Investigational Site Number 6805
Berlin, Germany, 10785
Investigational Site Number 6810
Berlin, Germany, 10713
Investigational Site Number 6807
Erbach, Germany, 64711
Investigational Site Number 6803
Essen, Germany, 45122
Investigational Site Number 6809
Hannover, Germany, 30625
Investigational Site Number 6804
Ludwigshafen, Germany, 67063
Investigational Site Number 6815
Minden, Germany, 32429
Investigational Site Number 6802
Münster, Germany, 48149
Investigational Site Number 6806
Wiesbaden, Germany, 65191
Hungary
Investigational Site Number 7101
Budapest, Hungary, 1076
Investigational Site Number 7103
Budapest, Hungary, 1145
Investigational Site Number 7108
Esztergom, Hungary, 2500
Investigational Site Number 7105
Veszprém, Hungary, 8200
Lithuania
Investigational Site Number 7402
Klaipeda, Lithuania, LT-92288
Investigational Site Number 7403
Siauliai, Lithuania, LT-76231
Investigational Site Number 7401
Vilnius, Lithuania, LT-08661
Mexico
Investigational Site Number 7501
Chihuahua, Mexico, 31203
Investigational Site Number 7502
Guadalajara, Mexico, 45110
Poland
Investigational Site Number 7709
Gdansk, Poland, 80-803
Investigational Site Number 7710
Lodz, Poland, 93-513
Investigational Site Number 7701
Warszawa, Poland, 02-097
Investigational Site Number 7703
Warszawa, Poland, 02-957
Investigational Site Number 7707
Warszawa 44, Poland, 04-141
Romania
Investigational Site Number 7806
Bucuresti, Romania, 050098
Investigational Site Number 7803
Bucuresti, Romania, 020125
Investigational Site Number 7805
Cluj-Napoca, Romania, 400012
Investigational Site Number 7807
Cluj-Napoca, Romania, 400012
Investigational Site Number 7808
Timisoara, Romania, 300736
Russian Federation
Investigational Site Number 7907
Kazan, Russian Federation, 420021
Investigational Site Number 7904
Nizhny Novgorod, Russian Federation, 603126
Investigational Site Number 7906
Nizhny Novgorod, Russian Federation, 603076
Investigational Site Number 7909
Nizhny Novgorod, Russian Federation, 603000
Investigational Site Number 7912
Novosibirsk, Russian Federation, 630007
Investigational Site Number 7910
Rostov-On-Don, Russian Federation, 344085
Investigational Site Number 7905
Smolensk, Russian Federation, 214019
Investigational Site Number 7911
St-Petersburg, Russian Federation, 194044
Turkey
Investigational Site Number 8310
?stanbul, Turkey
Investigational Site Number 8304
Edirne, Turkey
Investigational Site Number 8308
Istanbul, Turkey
Investigational Site Number 8309
Istanbul, Turkey, 34390
Investigational Site Number 8312
Istanbul, Turkey
Investigational Site Number 8315
Istanbul, Turkey, 34400
Investigational Site Number 8301
Izmir, Turkey, 35340
Investigational Site Number 8303
Izmir, Turkey, 35380
Investigational Site Number 8305
Izmir, Turkey, 35100
Investigational Site Number 8302
Izmit, Turkey, 41380
Investigational Site Number 8314
Trabzon, Turkey, 61080
Ukraine
Investigational Site Number 8507
Chernihiv, Ukraine, 14029
Investigational Site Number 8501
Dnipropetrovsk, Ukraine, 49027
Investigational Site Number 8511
Donets'K, Ukraine, 83099
Investigational Site Number 8506
Kharkiv, Ukraine, 61018
Investigational Site Number 8504
Kharkiv, Ukraine, 61178
Investigational Site Number 8508
Kiev, Ukraine, 03110
Investigational Site Number 8512
Lutsk, Ukraine, 43005
Investigational Site Number 8505
Lviv, Ukraine, 79010
Investigational Site Number 8510
Poltava, Ukraine, 36011
Investigational Site Number 8503
Vinnytsya, Ukraine, 21005
Investigational Site Number 8502
Zaporizhzhya, Ukraine, 69000
United Kingdom
Investigational Site Number 8709
Liverpool, United Kingdom, L9 7LJ
Investigational Site Number 8704
London, United Kingdom, SW17 0QT
Investigational Site Number 8701
London, United Kingdom, E1 1BB
Investigational Site Number 8706
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Investigational Site Number 8705
Nottingham, United Kingdom, NG7 2UH
Investigational Site Number 8708
Plymouth, United Kingdom, PL6 5BX
Investigational Site Number 8707
Salford, United Kingdom, M6 8HD
Investigational Site Number 8702
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00622700     History of Changes
Other Study ID Numbers: EFC6260, HMR1726D-3005, 2006-001152-12
Study First Received: February 14, 2008
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi:
MS
Clinically Isolated Syndrome
CIS
CDMS
relapses

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014