International Clinical Trials
Australia
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Belgium
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.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, Global
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, Global
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: Jose Ranawaya, (403) 944-4245
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
Croatia
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
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(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
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
Germany
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
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
Netherlands
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Russia
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Serbia and Montenegro
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Spain
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study II (CARE-MSSM II): Randomized, rater-blinded study to compare safety and efficacy of high-dose alemtuzumab, low-dose alemtuzumab, and Rebif in patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 1200
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
Ukraine
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com
United Kingdom
Agent(s): Cannador (cannabis extract)
Treatment Mode of Action: To improve muscle stiffness and pain
Study Description/Purpose: Randomized, double-blind, placebo-controlled study to determine safety and efficacy of oral cannabis for relief of muscle stiffness and pain in MS.
Institution(s): Peninsula Medical School, Plymouth, UK, and others in the United Kingdom
Type of MS: All types, stable for at least 6 months
Number of Subjects: 400
Funding: Weleda AG and IKF
Enrollment Information: Suzi Reilly +44-1752-315 250, ext. 250, www.msmusecstudy.com
Agent(s): experimental agent, alemtuzumab, vs. active comparator, Rebif® (interferon beta-1a)
Treatment mode of action: To affect immune function
Study Description/Purpose: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study I (CARE-MSSM I): Randomized, rater-blinded study to compare safety and efficacy of alemtuzumab and Rebif in patients who have not previously received treatment to suppress multiple sclerosis, except steroids.
Institution(s): Multicenter, worldwide
Type of MS: RR
Number of Subjects: 525
Funding: Genzyme Corporation, Bayer
Enrollment Information: Genzyme Medical Information, (800) 745-4447, medinfo@genzyme.com