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International Clinical Trials

International Clinical Trials

Australia

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information:  http://www.TheTopicStudy.org/au/

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: http://www.mstrials.org.au/find-a-ms-trial/ 

Belarus

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Iryna Alokhina, ia@verumua.com

Canada

Agent: Tysabri® (natalizumab)
Treatment mode of action: To affect immune function
Study Description/Purpose: Tysabri Global Observational Program in Safety (TYGRIS), to obtain long-term safety data in multiple sclerosis
Treatment mode of action: To affect immune function
Institution(s): Multiple, United States and Canada
Type of MS: Relapsing forms
Number of Subjects: 2500
Funding: Biogen Idec
Enrollment Information: neurologyclinicaltrials@biogenidec.com

Agent: BOTOX® (botulinum toxin type A)
Treatment mode of action: Treatment of neurogenic incontinence
Study Description/Purpose: Randomized, double-blinded, placebo-controlled study to determine safety and effectiveness
Institution(s): Multicenter, worldwide
Type of MS: All types, clinically stable for at least 3 months, EDSS of 6.5 or less
Number of Subjects: 405
Funding: Allergan
Enrollment Information: www.dignitystudy.com

Agent: BOTOX® (botulinum toxin type A)
Treatment mode of action: Treatment of neurogenic incontinence
Study Description/Purpose: Randomized, double-blinded, placebo-controlled study to determine safety and effectiveness
Institution(s): Multicenter, worldwide
Type of MS: All types, clinically stable for at least 3 months, EDSS of 7.0 to 8.0
Number of Subjects: 135
Funding: Allergan
Enrollment Information: www.dignitytoostudy.com

Agent: Interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blinded, randomized trial comparing interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily alone or in combination
Institution(s): Capital Health/University of Alberta, and others, North America
Type of MS: RR
Number of Subjects: 1000
Funding: NINDS
Enrollment Information: Pam Dumont, 780-407-1491

Agent: Interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blinded, randomized trial comparing interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily alone or in combination
Institution(s): Ottawa Hospital, and others, North America
Type of MS: RR
Number of Subjects: 1000
Funding: NINDS
Enrollment Information: Dawn Carle, 613-737-8104, ext. 4

Agent: Interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blinded, randomized trial comparing interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily alone or in combination
Institution(s): St. Michael’s Hospital, and others, North America
Type of MS: RR
Number of Subjects: 1000
Funding: NINDS
Enrollment Information: Chantal Bidal, 416- 864-5176

Agent: Interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blinded, randomized trial comparing interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily alone or in combination
Institution(s): University of Calgary/Foothills Hospital, and others, North America
Type of MS: RR
Number of Subjects: 1000
Funding: NINDS
Enrollment Information: Andrew Liu, 403-944-2589

Agent: Interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blinded, randomized trial comparing interferon (IFN) B-1a weekly and glatiramer acetate (GA) daily alone or in combination
Institution(s): St. Michael's Hospital, Toronto, and others, North America
Type of MS: RR
Number of Subjects: 1000
Funding: NINDS
Enrollment Information: Lisa Brandeis, 416-864-6060, ext. 2627

Agent: Lipitor® (atorvastatin, a cholesterol-lowering drug)
Treatment Mode of Action: To affect immune function
Study Description/Purpose: A randomized, double-blind, placebo-controlled, multicenter study to evaluate the effectiveness and safety in patients at high risk for MS
Institution(s): Montreal Neurological Institute, and others in the United States and Canada
Type of MS: Clinically Isolated Syndrome (CIS, a single, isolated neurologic event suggesting loss of nerve-insulating myelin)
Number of Subjects: 152
Funding: DAIT/NIAID
Enrollment Information: Natasha Roberts, 514-398-6052

Finland

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: http://www.TheTopicStudy.org/fi/  

France

Agent: 3-4 diaminopyridine
Treatment Mode of Action: To improve fatigue
Study Description/Purpose: Double-blind, placebo controlled study to determine safety and effectiveness
Institution(s): CHU de Rennes, FRANCE
Type of MS: All types
Number of Subjects: 60
Funding: French Health Ministry
Enrollment Information: gilles.edan@chu-rennes.fr

Agent: Cyclophosphamide vs. methylprednisolone
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blind, randomized study to determine effectiveness in people with recent secondary-progressive MS
Institution(s): Pellegrin Hospital and others, France
Type of MS: SP
Number of Subjects: 360
Funding: French Health Ministry
Enrollment Information: Bruno Brochet, MD, bruno.brochet@chu-bordeaux.fr

Agent(s): PI-2302, co-polymer
Treatment Mode of Action: To affect immune function
Study Description/Purpose: A randomized, double-blind, placebo-controlled study to determine safety, tolerability, and pharmacokinetics of multiple doses
Institution(s): Multiple, France
Type of MS: SP
Number of Subjects: up to 53
Funding: Peptimmune
Enrollment Information: andre.paquin@biotrial.com, meriam.djemai@biotrial.com, 33-02-9959-9191

Agent: Progesterone and estradiol (sex hormones)
Treatment Mode of Action: To affect immune function
Study Description/Purpose: A double-blind study to determine if treatment with progesterone and estradiol can prevent post-partum relapses in women with multiple sclerosis.
Institution(s): Hospices Civils de Lyon, and others, Europe
Type of MS: Relapsing MS
Number of Subjects: 300
Funding: French Ministry of Health
Enrollment Information: Juliana Achiti, MD, popartmus@edmus.org

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: pclavelou@chu-clermontferrand.fr 

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Helene.merle@chu-lyon.fr  

Germany

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: http://www.dmsg.de/multiple-sklerose-news/index.php?kategorie=forschung&cnr=31&anr=1818&searchkey=topic&wholewords=0  

Israel

Agent: T cell vaccination
Treatment Mode of Action: To affect immune function
Study Description/Purpose: Double-blind study to determine safety and effectiveness
Institution(s): Sheba Medical Center, Tel-Hashomer, Israel
Type of MS: At risk for MS
Number of Subjects: 76
Funding: Horowitz Foundation
Enrollment Information: Dr. Anat Achiron, 3-530-932

Italy

Agent: Rebif® + estroprogestins
Treatment Mode of Action: To affect immune function
Study description/purpose: A randomized, single-blinded, study to test safety and effectiveness
Institution(s): University of Rome “La Sapienza,” and others, Italy
Type of MS: RR
Number of subjects: 180
Funding: University of Rome “La Sapienza”
Enrollment Information: fabiana.marineli@uniroma1.it

Agent: Progesterone and estradiol (sex hormones)
Treatment Mode of Action: To affect immune function
Study Description/Purpose: A double-blind study to determine if treatment with progesterone and estradiol can prevent post-partum relapses in women with multiple sclerosis.
Institution(s): Hospices Civils de Lyon and others, Europe
Type of MS: Relapsing MS
Number of Subjects: 300
Funding: French Ministry of Health
Enrollment Information: Juliana Achiti, MD, popartmus@edmus.org

Mexico

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Dr. Jose Manuel Aleman Pedroza, jaleman@uag.mx, Hospital Dr. Angel Leaño; Dr. Ildefonso Rodríguez Leyva,  neurologiahc@prodigy.net.mx, Hospital Ignacio Morones Prieto; Dr. Arturo Violante Villanueva; aviolantev@yahoo.com.mx, Instituto Nacional de Neurología y Neurocirugía, Clinica de Esclerosis Multiple; Dr. Minerva López Ruíz; lopez69ruiz@hotmail.com, Hospital General de México; Dr. Juan Fernando Gongora Rivera, fernando.gongora@hotmail.com, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"  

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information:  Dr. Juan Fernando Gongora Rivera, fernando.gongora@hotmail.com, Hospital Universitario "Dr. Jose Eleuterio Gonzalez;" Dr. Minerva López Ruíz, lopez69ruiz@hotmail.com, Hospital General de México; Dr. Arturo Violante Villanueva, aviolantev@yahoo.com.mx, Hospital Ángeles del Pedregal; Dr. Ildefonso Rodríguez Leyva, neurologiahc@prodigy.net.mxirdzle@gmail.com, ilrole@yahoo.com.mx, Hospital Ignacio Morones Prieto  

Morocco

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Mu ltiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Pr Ouhabi ; ouhabiha@hotmail.com  

Thailand

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: JT.Tibung@sanofi-aventis.com

Tunisia

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Riadh Gouider; rg@gnet.tn

Turkey 

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: Prof. Dr. Gülşen F.Akman Demir; akmandem@istanbul.edu.tr

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Prof. Dr. Gülşen F.Akman Demir; akmandem@istanbul.edu.tr  

Ukraine

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: Iryna Alokhina, ia@verumua.com

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people with relapsing forms of MS.
Institution(s): Multiple, worldwide
Type of MS: Relapsing
Number of Subjects: 1110
Funding: sanofi-aventis
Enrollment Information: Iryna Alokhina, ia@verumua.com 

United Kingdom

Agent(s): teriflunomide
Treatment mode of action: Immune modulator (reduces immune system over activity)
Study Description/Purpose: An randomized, double-blind, placebo-controlled, parallel group study to evaluate the effectiveness and safety of two doses of teriflunomide versus placebo in people at high risk for MS.
Institution(s): Multiple, worldwide
Type of MS: Clinically Isolated Syndrome (CIS, a single isolated neurological event suggestive of MS and involving loss of nerve – insulating myelin, such as focal weakness, or numbness, or coordination problems, or decrease in vision in one eye)
Number of Subjects: 780
Funding: sanofi-aventis
Enrollment Information: http://www.TheTopicStudy.org/uk/ 
 

 

Rebif is a registered trademark of Ares Trading S.A.

Tysabri is a registered trademark of Elan Pharmaceuticals, Inc.

Botox is a registered trademark of Allergan, Inc.

Lipitor is a registered trademark of Pfizer.