糖心原创

Clinical Neurology

Trials

Current and completed clinical trials
糖心原创TitleStatusResults
Cambridge Genetics

The primary aim of this project is to identify heritable variation conferring susceptibility to multiple sclerosis. Secondary aims are to identify heritable variation influencing disease course, features and response to treatment (pharmacogenomics). We believe that this knowledge will provide invaluable insights into the pathogenesis of the disease, which in turn will suggest new opportunities for further research and perhaps ultimately even treatment.

Recruiting

The International Multiple Sclerosis Genetics ConConsortium & The Wellcome Trust Case ConControl Consortium 2132 Nature 476,214–
Sanofi Aventis EFC 6260

An international multicentre randomised double blind placebo controlled parallel group study to evaluate the efficacy and safety of 2 year treatment with 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of MS

Ongoing  
Sanofi Aventis LTS 6050

A long term extension of the multinational double blind placebo controlled study EFC 6049 to document the safety of 2 doses of Teriflunomide (7 and 14mg) in patients with relapsing M

ongoing  
Roche Oratorio

A multi centre randomised parallel group double blinded placebo controlled study to evaluate the efficacy and safety of Ocrelizumab in adults with Primary Progressive MS

recruiting  
Apitope 

Safety and proof of principle study of atx-ms-1467 in patients with relapsing ms Open label upward titration over 5 dose levels and using 2 routes of administration ( im and sc

recruiting  
Biogen Idec Decide

A multicentre double blind randomised parallel group Monothrerapy active control study to determine the efficacy and safety of DaclizUmab High yield process (DAC HYP) versus Avonex ( interferon b-1a) in patients with relapsing remitting M

recruiting  
Biogen Idec Advance

A multicentre randomised double blind parallel group placebo controlled study to evaluate the efficacy and safety of PEGylated Interferon Beta-1a(B11B017)in subjects with relapsing M

recruiting  
Novartis 2399 Single arm open label multicentre study evaluating the long term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of MS ongoing  
Novartis 2320

A 3 month blinded randomised multicentre placebo controlled study to evaluate the effect of the treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of MS

completed  
Biogen Idec 203 A multicentre open label extension study to evaluate the safety and efficacy of Daclizumab (DAC HYP) high yield process as a monotherapy in subjects with MS who have completed treatment in the 202 (Selection) study ongoing  
Biogen Idec 202 Selection A multicentre Double blind placebo controlled dose ranging study to determine the safety and efficacy of Daclizumab (DAC HYP) as a monotherapy treatment in subjects with relapsing remitting MS and a double blind multicentre extension study to evaluate the safety and efficacy of DAC HYP in subjects with MS who have completed treatment in the 201 (Select) study

Ongoin

 
Roche 糖心原创 Protocol WA21493 Phase II, multicenter, randomized, parallel-group, assessor and partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis.

ongoing

 

Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Lancet. 2011 Nov 19;378(9805):1779-87. Epub 2011 Oct 31.

Genmab A/STrial ID GEN414 A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients. Not recruiting yet -
Biogen DAC HYP studyProtocol 205-MS-201 Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging 糖心原创 to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis.

Completed

-
UCB Pharma SAProtocol No C32322 Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.

Completed

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GSK 糖心原创Protocol A4M105038 Randomised, Double-blind, Placebo-controlled Parallel-group, Dose-ranging 糖心原创 to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150-1200 mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis.

Completed

-
Novartis 糖心原创Protocol No CFTY720D2301 A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.

ongoing

Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS 糖心原创 Group. N Engl J Med. 2010 Feb 4;362(5):387-401. Epub 2010 Jan 20

Cupid 糖心原创Protocol No CUPID2005 Cannabinoid use in Progressive Inflammatory Brain Disease (CUPID) study.

Ongoing

Recruitment

ended

-
Musec 糖心原创Protocol No 2005-005263-29 Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. Completed -
GWPharma PainProtocol GWMS0501 A double blind, randomised, placebo controlled, parallel group study of Sativex when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. Completed -
MBP BioMSProtocol MBP8298-01 A double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. Completed

Darlington C.Curr Opin Mol Ther. 2007 Aug;9(4):398-402.

Serono Cladribine 糖心原创Protocol 25643 A phase III, randomized, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral cladribine in subjects with relapsing, remitting multiple sclerosis (RRMS) (Serono Protocol No 25643) (EudraCT No 2004-005 148-28) Completed

Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sørensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY 糖心原创 Group.

N Engl J Med. 2010 Feb 4;362(5):416-26. Epub 2010 Jan 2

GW Pharma A double blind, randomised, placebo controlled, parallel group study of Sativex in subjects with symptoms of spasticity due to multiple sclerosis GWCL0403 Completed -
CentocorC0743T06 A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging 糖心原创 of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in subjects with Relapsing-remitting Multiple Sclerosis. Completed

 

Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-80

MillenniumM120204-063 A Phase 2a Magnetic Resonance Imaging 糖心原创 of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis. terminated -
Mecombin Biogen A multi-center, double blind, randomized, placebo controlled, parallel group trial investigating methylprednisolone in combination with Interferon-beta 1a for the treatment of relapsing-remitting multiple sclerosis. Completed

Ravnborg M, Sørensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholomé E, Constantinescu CS, Beer K, Garde E, Sperling B.

Lancet Neurol. 2010 Jul;9(7):672-80. Epub 2010 Jun 9

Teva Oral CopaxoneProtocol GA/7026 A pilot, multicenter, open-label, one group study to explore the efficacy, tolerability and safety of an oral once-daily 600 mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). Completed -
Merck & CoProtocol 003-00 A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups 糖心原创 to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remtting Multiple Sclerosis as measured by MRI. Terminated -
AbbottProtocol M03-654 A 24-week, randomized, double-blind, parallel-group, placebo-controlled, dose finding, safety, tolerability and efficacy study of the human Anti-IL-12 Antibody ABT-874 in subjects with multiple sclerosis with a 24-week double-blind, active extension phase. Completed -
 Teva Precise 糖心原创[Covance]   Protocol No GA/9010 A multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the effect of early glatiramer acetate treatment in delaying the conversion of clinically definite multiple sclerosis (CDMS) of subjects presenting with a clinically isolated syndrome (CIS). Completed

Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, King J, Komoly S, Lubetzki C, Montalban X, Myhr KM, Ravnborg M, Rieckmann P, Wynn D, Young C, Filippi M; PreCISe study group. Lancet. 2009 Oct 31;374(9700):1503-11. Epub 2009 Oct 6. Erratum in: Lancet. 2010 Apr 24;375(9724):1436.

 SeronoRebif v Copaxone[Esoterix Clinical Trials Service][Covance]   Protocol No 24735 A phase IV, multicenter, open label, radomized, study of Rebif R 44 mcg administered three times per week by subcutaneous injection compared with CopaxoneR 20 mg administered daily by subcutaneous injection in the treatment of relapsing remitting multiple sclerosis. Completed

Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag BM; study group.Lancet Neurol. 2008 Oct;7(10):903-14. Epub 2008 Sep 11

GSKProtocol No BRL-49653/452 A randomised, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability and efficacy of six months' administration of AVANDIA in subjects with relapsing-remitting multiple sclerosis. Completed -
Wyeth Extension3066A2-210-WW A multicenter, randomised, double blind, long-term extension study to determine the safety, tolerability and preliminary efficacy of CCI-779 in subjects with relapsing multiple sclerosis. Completed -
WyethProtocol No 3066A2 205WW A randomized, double-blind, placebo-controlled, fixed-flexible-dose, parallel-group, multicenter study to determine the dose and the safety, tolerability, and preliminary efficacy of CCI-779 in subjects with relapsing multiple sclerosis. Completed -
GamppProtocol No:GAM-107 A prospective, multicentre, randomised, stratified parallel group design, confirmatory study to investigate the effect of Octagam treatment on the relapse rate during the postpartum period in patients suffering from relapsing/remitting multiple sclerosis. Completed
CannabisProtocol NoMREC/00/6/05 A multicentre randomised controlled trial of Cannabinoids on spasticity in multiple sclerosis. Completed
GWPharma A double blind randomised placebo controlled parallel group study of cannabis based medicine extract (CBME) in patients suffering detrusor over activity associated with multiple sclerosis. Completed Manuscript in preparation
IGIV-CBAY 41-1000 IMP 100434 Randomized, double-blind, placebo-controlled study to compare the effects of different dose regimens of IGIV-Chromatography (IGIV-C), 10% treatment on relapse rates in patients with multiple sclerosis. Completed -
Prisms Long-term follow up studySerono 糖心原创 22930 Long term efficacy and safety phase IV follow up of the Prisms cohort. Completed
Pharmacogenomic 糖心原创Protocol No GA-0&I/001 The Pharmacogenomics of Glatiramer Acetate: study of the genetic basis of responsiveness to Glatiramer Acetate (oral and injectable) in multiple sclerosis patients. Completed
MRI Follow-up 糖心原创 Protocol No 9003A A multi national, multicenter, follow-up study to assess the neurological and MRI status of subjects who completed the 9003 study (18 months). Completed -
BMS IM101-200 A phase II, randomized, double-blind, placebo controlled study to evaluate the preliminary efficacy, pharmacokinetics and immunogenicity of BMS-188667 administered to subjects with relapsing-remitting multiple sclerosis. Terminated -
Active Biotech Protocol No 01506203 A double-blind, randomised, phase II study of ABR-215062 versus placebo in patients with relapsing multiple sclerosis. Completed
Antegren Protocol No 01506203 A randomized, multicenter, double-blind, placebo-controlled safety, tolerability and dose evaluation study of intravenous AntegrenTM (Natalizumab) at two dose levels using magnetic resonance imaging in subjects with multiple sclerosis. Completed
Amgen: Anakinra IL-1ra 990141 Randomized, double-blind, placebo-controlled trial of Anakinra in the treatment of multiple sclerosis. Completed -
Teva Promise A multi-national, multi-centre, double-blind, placebo controlled study to evaluate the efficacy, tolerability and safety of Glatiramer Acetate for injection in Primary Progressive Multiple Sclerosis Patients. Completed
Teva CoralGA/7023 A multinational, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of 2 doses (5mg and 50mg) of glatiramer acetate administered orally in RRMS patients. Completed
IVIGBAY 10-5230/013 European multicentre randomised placebo-controlled double-blind study to evaluate the efficacy and safety of intravenous (IVIG) Immune Globulin (IVIG) in patients with secondary progressive multiple sclerosis. Completed
AstraProtocol No SA-M27-0002 A multicenter baseline controlled double blind study on the safety and tolerability in patients with relapsing-remitting multiple sclerosis receiving multiple doses of ATM-027 or placebo. Completed -
ETOMS Early treatment of MS. Completed
Cop1 TevaProtocol 9003 Multi-national, multi-centre, randomised, double-blind, placebo controlled study, extended by open label treatment to study the effect of Copaxone (copolymer-1) on disease activity as measured by cerebral magnetic resonance imaging (MRI) in patients with relapsing-remitting multiple sclerosis. Completed
Rebif Protocol 6789 A multicentre, randomised, double-blind, placebo controlled, phase III study of subcutaneous Rebif (recombinant-human interferon-beta) in the treatment of relapsing-remitting multiple sclerosis. Completed Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) 糖心原创 Group. Lancet. 1998 Nov 7;352(9139):1498-504. Erratum in: Lancet 1999 Feb 20;353(9153):678.
Rebif Protocol 6954 A multicentre, randomised, doubleblind, placebo controlled, phase III study of subcutaneous Rebif (recombinant-human interferon-beta) in the treatment of secondary progressive multiple sclerosis (SPECTRIMS). Completed

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Clinical Neurology

School of Medicine
The 糖心原创
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