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- |||| Trial completion, Patient reported outcomes: Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) (clinicaltrials.gov) - Aug 8, 2014
P4, N=298, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed
- ||| Zeposia (ozanimod) / BMS
Enrollment closed, Trial primary completion date: TOUCHSTONE: Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (clinicaltrials.gov) - Jul 23, 2014
P2, N=199, Active, not recruiting, Sponsor: Receptos, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2014 --> Oct 2014
- amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
New P1 trial: A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303 (clinicaltrials.gov) - Jul 17, 2014
P1, N=0, Not yet recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
- |||| fingolimod / Generic mfg.
Trial primary completion date: PARADIGMS: Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis (clinicaltrials.gov) - Jul 12, 2014
P3, N=190, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2014 --> Oct 2014 Trial primary completion date: May 2017 --> Sep 2017
- mocravimod (KRP-203) / Priothera
Trial primary completion date: A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies (clinicaltrials.gov) - Jun 26, 2014
P1, N=10, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: May 2017 --> Sep 2017 Trial primary completion date: May 2015 --> Dec 2015
- Mayzent (siponimod) / Novartis
Enrollment change: Pharmacokinetics of BAF312 in Patients With Hepatic Impairment (clinicaltrials.gov) - Jun 17, 2014
P1, N=35, Completed, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: May 2015 --> Dec 2015 N=48 --> 35
- | Mayzent (siponimod) / Novartis
Biomarker, Trial completion, Retrospective data, Review, Enrollment change, Journal: Pharmacokinetics of BAF312 in Patients With Hepatic Impairment (clinicaltrials.gov) - Jun 17, 2014
P1, N=35, Completed, Sponsor: Novartis Pharmaceuticals
N=48 --> 35 Recruiting --> Completed | N=48 --> 35
- mocravimod (KRP-203) / Priothera
Enrollment change: Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients (clinicaltrials.gov) - Jun 4, 2014
P2, N=35, Terminated, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed | N=48 --> 35 N=72 --> 35
- Trial primary completion date: Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON) (clinicaltrials.gov) - Jun 3, 2014
P2, N=2, Completed, Sponsor: Novartis Pharmaceuticals
N=72 --> 35 Trial primary completion date: Dec 2016 --> May 2014
- ||| Trial initiation date: STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (clinicaltrials.gov) - Jun 3, 2014
P4, N=7000, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Dec 2016 --> May 2014 Initiation date: Nov 2010 --> Jun 2012
- Enrollment change: Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON) (clinicaltrials.gov) - Jun 3, 2014
P2, N=2, Completed, Sponsor: Novartis Pharmaceuticals
Initiation date: Nov 2010 --> Jun 2012 N=126 --> 2
- ||| Enrollment closed: Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms (clinicaltrials.gov) - Jun 3, 2014
P4, N=151, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
N=126 --> 2 Recruiting --> Active, not recruiting
- Trial completion: Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON) (clinicaltrials.gov) - Jun 3, 2014
P2, N=2, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Completed
- ||||||| Trial completion: Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - Jun 3, 2014
P3, N=162, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Completed
- | Trial initiation date, HEOR: A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 (clinicaltrials.gov) - Jun 3, 2014
P4, N=50, Recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Initiation date: Jul 2012 --> Oct 2012
- amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
New P1 trial: Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease (clinicaltrials.gov) - May 26, 2014
P1, N=3, Recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
- ||| amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Enrollment closed: Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - May 20, 2014
P2a, N=140, Active, not recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
Initiation date: Jul 2012 --> Oct 2012 Recruiting --> Active, not recruiting
- ||||| Enrollment closed: INFORMS: This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (clinicaltrials.gov) - May 20, 2014
P3, N=969, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- Mayzent (siponimod) / Novartis
Trial primary completion date: A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function (clinicaltrials.gov) - May 20, 2014
P1, N=48, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Trial primary completion date: Aug 2014 --> Aug 2014
- Mayzent (siponimod) / Novartis
Trial completion date: A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function (clinicaltrials.gov) - May 20, 2014
P1, N=48, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Aug 2014 --> Aug 2014 Trial completion date: Aug 2014 --> Aug 2014
- fingolimod / Generic mfg.
Clinical: Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya (clinicaltrials.gov) - May 14, 2014
P=N/A, N=20, Recruiting, Sponsor: Stony Brook University
- ||| amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Enrollment closed: Dose-finding Study of MT-1303 (clinicaltrials.gov) - May 11, 2014
P2, N=400, Active, not recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
Trial completion date: Aug 2014 --> Aug 2014 Recruiting --> Active, not recruiting
- ||||| fingolimod / Generic mfg.
New P4 trial: Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya (clinicaltrials.gov) - May 11, 2014
P4, N=400, Recruiting, Sponsor: McGill University
- ||| Ponvory (ponesimod) / J&J
New P1 trial: Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects (clinicaltrials.gov) - May 11, 2014
P1, N=116, Completed, Sponsor: Actelion
- Trial primary completion date: FingoHRV: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis (clinicaltrials.gov) - May 6, 2014
P=N/A, N=27, Completed, Sponsor: Kuopio University Hospital
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Mar 2014
- Trial completion date: FingoHRV: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis (clinicaltrials.gov) - May 6, 2014
P=N/A, N=27, Completed, Sponsor: Kuopio University Hospital
Trial primary completion date: Dec 2016 --> Mar 2014 Trial completion date: Dec 2016 --> Mar 2014
- Trial completion: FingoHRV: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis (clinicaltrials.gov) - May 6, 2014
P=N/A, N=27, Completed, Sponsor: Kuopio University Hospital
Trial completion date: Dec 2016 --> Mar 2014 Recruiting --> Completed
- || Mayzent (siponimod) / Novartis
Trial primary completion date: Safety and Efficacy of BAF312 in Dermatomyositis (clinicaltrials.gov) - May 4, 2014
P2, N=56, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Trial primary completion date: Nov 2015 --> Jan 2016
- || Mayzent (siponimod) / Novartis
Trial completion date: Safety and Efficacy of BAF312 in Dermatomyositis (clinicaltrials.gov) - May 4, 2014
P2, N=56, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Nov 2015 --> Jan 2016 Trial completion date: Nov 2015 --> Jan 2016
- Trial withdrawal: Safety and Efficacy of Fingolimod in MS Patients in China (clinicaltrials.gov) - Apr 28, 2014
P3, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Trial completion date: Nov 2015 --> Jan 2016 Not yet recruiting --> Withdrawn
- Trial initiation date: Safety and Efficacy of Fingolimod in MS Patients in China (clinicaltrials.gov) - Apr 28, 2014
P3, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Withdrawn Initiation date: Dec 2013 --> Jun 2014
- Enrollment change: Safety and Efficacy of Fingolimod in MS Patients in China (clinicaltrials.gov) - Apr 28, 2014
P3, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Initiation date: Dec 2013 --> Jun 2014 N=132 --> 0
- Ponvory (ponesimod) / J&J
New P1 trial: Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects (clinicaltrials.gov) - Apr 28, 2014
P1, N=6, Completed, Sponsor: Actelion
- | Tysabri (natalizumab) / Biogen, Royalty
Trial termination: TOFIINGO: Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod (clinicaltrials.gov) - Apr 21, 2014
P3, N=142, Terminated, Sponsor: Novartis Pharmaceuticals
N=132 --> 0 Completed --> Terminated; Based on recent publications, determination of natalizumub washout period was no longer relevant.
- ||||| Rebif (human IFN-?-1a) / EMD Serono
Trial initiation date: Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. (EUDRACT) - Apr 14, 2014
P3, N=1176, Ongoing, Sponsor: Merck KGaA
Completed --> Terminated; Based on recent publications, determination of natalizumub washout period was no longer relevant. Initiation date: Mar 2014 --> Mar 2014
- Trial initiation date: Study of FTY720 in Patients With Uveitis (clinicaltrials.gov) - Apr 14, 2014
P2, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Initiation date: Mar 2014 --> Mar 2014 Initiation date: Sep 2013 --> Nov 2013
- Trial withdrawal: Study of FTY720 in Patients With Uveitis (clinicaltrials.gov) - Apr 14, 2014
P2, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Initiation date: Sep 2013 --> Nov 2013 Not yet recruiting --> Withdrawn
- Enrollment change: Study of FTY720 in Patients With Uveitis (clinicaltrials.gov) - Apr 14, 2014
P2, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Withdrawn N=30 --> 0
- fingolimod / Generic mfg.
Trial initiation date: The Gilenya Pregnancy Registry (clinicaltrials.gov) - Mar 23, 2014
P=N/A, N=500, Recruiting, Sponsor: Novartis Pharmaceuticals
N=30 --> 0 Initiation date: Apr 2011 --> Oct 2011
- New P4 trial: Voidaanko aivojen mikroglia-solukon aktiivisuutta v (EUDRACT) - Feb 27, 2014
P4, N=10, Ongoing, Sponsor: Turku University Hospital
- |||| Enrollment open: BiobankII: Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis (clinicaltrials.gov) - Feb 26, 2014
P4, N=250, Recruiting, Sponsor: Heinrich-Heine University, Duesseldorf
Initiation date: Apr 2011 --> Oct 2011 Not yet recruiting --> Recruiting
- | phenoxodiol (NV06) / MEI
Trial completion: Phenoxodiol in Treating Patients With Refractory Solid Tumors (clinicaltrials.gov) - Feb 19, 2014
P1, N=36, Completed, Sponsor: Novogen
Not yet recruiting --> Recruiting Recruiting --> Completed
- |||||||||| Rebif (human IFN-?-1a) / EMD Serono
New P3 trial: Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. (EUDRACT) - Feb 19, 2014
P3, N=1176, Ongoing, Sponsor: Merck KGaA
- | Ponvory (ponesimod) / Juvise Pharma, Vanda
New P1 trial: Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects (clinicaltrials.gov) - Feb 19, 2014
P1, N=15, Not yet recruiting, Sponsor: Actelion
- New P1/2 trial: FINGORETT: Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome (clinicaltrials.gov) - Feb 10, 2014
P1/2, N=6, Recruiting, Sponsor: University Hospital, Basel, Switzerland
- New P4 trial: ANSG: Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS (clinicaltrials.gov) - Jan 27, 2014
P4, N=30, Recruiting, Sponsor: Jochen Vehoff
- || Zeposia (ozanimod) / BMS
New P3 trial: Radiance: Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (clinicaltrials.gov) - Jan 26, 2014
P3, N=1200, Recruiting, Sponsor: Receptos, Inc.
- ||| Enrollment change: STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (clinicaltrials.gov) - Jan 20, 2014
P4, N=7000, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed N=2000 --> 7000
- ||| Enrollment change: Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - Jan 16, 2014
P4, N=178, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
N=2000 --> 7000 N=226 --> 178
- |||||| Enrollment open: INFORMS: This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (clinicaltrials.gov) - Jan 16, 2014
P3, N=940, Recruiting, Sponsor: Novartis Pharmaceuticals
N=226 --> 178 Active, not recruiting --> Recruiting