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133 Mechanisms of Action

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||||||||||  disitertide (P144) / Avadel, Digna Biotech
Trial completion:  Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study (clinicaltrials.gov) -  Feb 7, 2013
P2, N=38, Completed,  Sponsor: ISDIN
Recruiting --> Completed

||||||||||  duloxetine / Generic mfg.
Enrollment change:  A Study to Test the Use of Duloxetine for Pain in MS (clinicaltrials.gov) -  Feb 5, 2013
P2/3, N=38, Completed,  Sponsor: Brown, Theodore R., M.D., MPH
Recruiting --> Completed N=60 --> 38

|||||||||| Clinical: Neuromuscular Ultrasound in ALS (clinicaltrials.gov) - Feb 5, 2013
P=N/A, N=50, Recruiting, Sponsor: Duke University

|||||||||| New P2a trial: Gilenya in Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Feb 5, 2013
P2a, N=30, Recruiting, Sponsor: Massachusetts General Hospital

||||||||||  duloxetine / Generic mfg.
Trial completion:  A Study to Test the Use of Duloxetine for Pain in MS (clinicaltrials.gov) -  Feb 5, 2013
P2/3, N=38, Completed,  Sponsor: Brown, Theodore R., M.D., MPH
N=60 --> 38 Recruiting --> Completed

|||||||||| Trial completion, IO biomarker: Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis (clinicaltrials.gov) - Feb 4, 2013
P1, N=40, Completed, Sponsor: Johns Hopkins University
Recruiting --> Completed Recruiting --> Completed

||||||||||  disitertide (P144) / Avadel, Digna Biotech
Enrollment change, IO biomarker:  Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis (clinicaltrials.gov) -  Jan 30, 2013
P2, N=56, Completed,  Sponsor: ISDIN
Recruiting --> Completed N=98 --> 56

||||||||||  disitertide (P144) / Avadel, Digna Biotech
Trial completion, IO biomarker:  Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis (clinicaltrials.gov) -  Jan 30, 2013
P2, N=56, Completed,  Sponsor: ISDIN
N=98 --> 56 Recruiting --> Completed

|||||||||| Trial completion: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis (clinicaltrials.gov) - Jan 30, 2013
P4, N=24, Completed, Sponsor: University of Medicine and Dentistry New Jersey
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Video: Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis (clinicaltrials.gov) - Jan 29, 2013
P=N/A, N=34, Recruiting, Sponsor: Ohio State University

|||||||||| Trial completion: Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) (clinicaltrials.gov) - Jan 29, 2013
P1/2, N=1000, Completed, Sponsor: Euromedic Specialist Clinics, Poland
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P3 trial: OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis (clinicaltrials.gov) - Jan 28, 2013
P3, N=700, Recruiting, Sponsor: Novartis Pharmaceuticals

||||||||||  NurOwn (MSC-NTF) / BrainStorm Cell Therap
New P2a trial, Stroma:  Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Jan 27, 2013
P2a, N=14, Active, not recruiting,  Sponsor: Hadassah Medical Organization

|||||||||| Trial completion, M&A: TOP MS: Therapy Optimization in Multiple Sclerosis (MS) (clinicaltrials.gov) - Jan 27, 2013
P=N/A, N=2878, Completed, Sponsor: Teva Neuroscience, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment change: FLORIMS: Flupirtine as Oral Treatment in Multiple Sclerosis (clinicaltrials.gov) - Jan 24, 2013
P2, N=30, Terminated, Sponsor: Charite University, Berlin, Germany
Active, not recruiting --> Completed N=80 --> 30

||||||||||  Sativex (nabiximols) / Jazz
New P2/3 trial:  Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease (clinicaltrials.gov) -  Jan 24, 2013
P2/3, N=60, Recruiting,  Sponsor: Ospedale San Raffaele

|||||||||| Enrollment open: Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis (clinicaltrials.gov) - Jan 24, 2013
P=N/A, N=173, Recruiting, Sponsor: Sunnybrook Health Sciences Centre
N=80 --> 30 Not yet recruiting --> Recruiting

||||||||||  Avastin (bevacizumab) / Roche
New P2 trial:  Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations (clinicaltrials.gov) -  Jan 24, 2013
P2, N=10, Recruiting,  Sponsor: Johns Hopkins University

||||||||||  Betaseron (IFN-β-1b) / Bayer
Trial termination:  Rehabilitation Study in MS Patients (clinicaltrials.gov) -  Jan 21, 2013
P4, N=4, Terminated,  Sponsor: Bayer
Not yet recruiting --> Recruiting Completed --> Terminated

|||||||||| Enrollment open: FingoHRV: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis (clinicaltrials.gov) - Jan 20, 2013
P=N/A, N=30, Recruiting, Sponsor: Kuopio University Hospital
Completed --> Terminated Not yet recruiting --> Recruiting

||||||||||  minocycline / Generic mfg.
Trial termination:  Mino in ON: Neuroprotection and Repair in Optic Neuritis (clinicaltrials.gov) -  Jan 20, 2013
P2a, N=6, Terminated,  Sponsor: University of Calgary
Not yet recruiting --> Recruiting Recruiting --> Terminated; Lack of recruitment

||||||||||  minocycline / Generic mfg.
Enrollment change:  Mino in ON: Neuroprotection and Repair in Optic Neuritis (clinicaltrials.gov) -  Jan 20, 2013
P2a, N=6, Terminated,  Sponsor: University of Calgary
Recruiting --> Terminated; Lack of recruitment N=45 --> 6

|||||||||| Biomarker, Enrollment change: Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - Jan 17, 2013
P4, N=531, Completed, Sponsor: Novartis Pharmaceuticals
N=45 --> 6 N=307 --> 531

||||||||||  GSK239512 / GSK
New P2 trial:  Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) -  Jan 17, 2013
P2, N=114, Active, not recruiting,  Sponsor: GlaxoSmithKline

|||||||||| Biomarker, Trial completion: Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - Jan 17, 2013
P4, N=531, Completed, Sponsor: Novartis Pharmaceuticals
N=307 --> 531 Active, not recruiting --> Completed

|||||||||| Trial completion: Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery (clinicaltrials.gov) - Jan 16, 2013
P=N/A, N=47, Completed, Sponsor: MedtronicNeuro
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P1 trial: Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS (clinicaltrials.gov) - Jan 16, 2013
P1, N=10, Recruiting, Sponsor: Royan Institute

||||||||||  sirolimus / Generic mfg.
Trial termination:  Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor (clinicaltrials.gov) -  Jan 15, 2013
P1/2, N=8, Terminated,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Completed --> Terminated; Due to slow recruitment.

||||||||||  Lemtrada (alemtuzumab) / Sanofi
Enrollment change, MRI, Metastases:  iCAMMS-IST: Advanced MRI Measures of Repair in Alemtuzumab Treated Patients (clinicaltrials.gov) -  Jan 15, 2013
P3, N=25, Active, not recruiting,  Sponsor: University of British Columbia
Completed --> Terminated; Due to slow recruitment. N=20 --> 25

||||||||||  sirolimus / Generic mfg.
Enrollment change:  Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor (clinicaltrials.gov) -  Jan 15, 2013
P1/2, N=8, Terminated,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=20 --> 25 N=13 --> 8

|||||||||| Enrollment closed, Immunomodulating: Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - Jan 15, 2013
P=N/A, N=18, Active, not recruiting, Sponsor: University of Wisconsin, Madison
N=13 --> 8 Recruiting --> Active, not recruiting

|||||||||| Trial completion: Locomotor Training in Persons With Multiple Sclerosis (clinicaltrials.gov) - Jan 14, 2013
P1/2, N=38, Completed, Sponsor: University of California, Los Angeles
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Tysabri (natalizumab) / Biogen, Royalty
Enrollment change:  TOFIINGO: Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod (clinicaltrials.gov) -  Jan 14, 2013
P4, N=158, Completed,  Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed N=600 --> 158

|||||||||| Metastases: Supraspinal Control of Lower Urinary Tract Function in Healthy Controls and Patients With Bladder Dysfunction (clinicaltrials.gov) - Jan 14, 2013
P=N/A, N=96, Recruiting, Sponsor: University of Zurich

||||||||||  Tysabri (natalizumab) / Biogen, Royalty
Trial completion:  TOFIINGO: Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod (clinicaltrials.gov) -  Jan 14, 2013
P4, N=158, Completed,  Sponsor: Novartis Pharmaceuticals
N=600 --> 158 Active, not recruiting --> Completed

|||||||||| Biomarker: Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC (clinicaltrials.gov) - Jan 10, 2013
P=N/A, N=40, Recruiting, Sponsor: University of Alabama at Birmingham

||||||||||  Isentress (raltegravir) / Merck (MSD)
New P2 trial:  INSPIREt: Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (clinicaltrials.gov) -  Jan 10, 2013
P2, N=24, Recruiting,  Sponsor: Queen Mary University of London

||||||||||  Betaseron (IFN-β-1b) / Bayer
HEOR:  BetaSleep: Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon (clinicaltrials.gov) -  Jan 9, 2013
P=N/A, N=300, Recruiting,  Sponsor: Bayer

||||||||||  Ocrevus (ocrelizumab) / Roche, Biogen
New P3 trial, P3 data:  Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG) (clinicaltrials.gov) -  Jan 8, 2013
P3, N=200, Recruiting,  Sponsor: Peter Fuhr

||||||||||  pepinemab (VX15) / Vaccinex
New P1 trial:  Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS (clinicaltrials.gov) -  Jan 8, 2013
P1, N=50, Recruiting,  Sponsor: Vaccinex Inc.

|||||||||| Enrollment change: Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis (clinicaltrials.gov) - Jan 2, 2013
P=N/A, N=50, Completed, Sponsor: Universita di Verona
Active, not recruiting --> Completed N=30 --> 50

|||||||||| Trial completion: Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis (clinicaltrials.gov) - Jan 2, 2013
P=N/A, N=50, Completed, Sponsor: Universita di Verona
N=30 --> 50 Recruiting --> Completed

||||||||||  glatiramer acetate / Generic mfg.
Trial termination:  An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) -  Jan 1, 2013
P3, N=178, Terminated,  Sponsor: Teva Pharmaceutical Industries
Recruiting --> Completed Active, not recruiting --> Terminated

||||||||||  glatiramer acetate / Generic mfg.
Enrollment change:  An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) -  Jan 1, 2013
P3, N=178, Terminated,  Sponsor: Teva Pharmaceutical Industries
Active, not recruiting --> Terminated N=1400 --> 178

||||||||||  Cinryze IV (C1 esterase inhibitor [human] IV) / Takeda
New P1 trial:  C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation (clinicaltrials.gov) -  Jan 1, 2013
P1, N=10, Completed,  Sponsor: Michael Levy

|||||||||| New P1 trial: Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS (clinicaltrials.gov) - Jan 1, 2013
P1, N=6, Completed, Sponsor: Royan Institute

|||||||||| New P1 trial: Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS (clinicaltrials.gov) - Jan 1, 2013
P1, N=10, Recruiting, Sponsor: Royan Institute

|||||||||| Clinical: Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation (clinicaltrials.gov) - Dec 30, 2012
P=N/A, N=8, Recruiting, Sponsor: The Cleveland Clinic

|||||||||| New P4 trial: BiobankII: Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis (clinicaltrials.gov) - Dec 20, 2012
P4, N=250, Recruiting, Sponsor: Heinrich-Heine University, Duesseldorf

||||||||||  ozanezumab (GSK 1223249) / GSK
New P2 trial:  Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (clinicaltrials.gov) -  Dec 18, 2012
P2, N=294, Active, not recruiting,  Sponsor: GlaxoSmithKline