Clinical Neurology
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Trials

For further details about clinical trials please contact Maxine Harrison on 0115 748 4077.

Current and completed clinical trials
Study Title Status Results
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

Genetic risk and a primary role for cell-mediated immune mechanisms in multiple sclerosis

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 Study

 

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

Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.

 

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/S

Trial ID GEN414

A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients. Not recruiting yet -

Biogen DAC HYP study

Protocol 205-MS-201

Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study 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 SA

Protocol 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

-

GSK Study

Protocol A4M105038

Randomised, Double-blind, Placebo-controlled Parallel-group, Dose-ranging Study 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 Study

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

A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.

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 Study Group. N Engl J Med. 2010 Feb 4;362(5):387-401. Epub 2010 Jan 20

Cupid Study

Protocol No CUPID2005

Cannabinoid use in Progressive Inflammatory Brain Disease (CUPID) study.

Ongoing

Recruitment

ended

-

Musec Study

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 Pain

Protocol 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 BioMS

Protocol 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

MBP-8298, a synthetic peptide analog of myelin basic protein for the treatment of multiple sclerosis.

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

Serono Cladribine Study

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

A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis

Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sørensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY Study 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 -

Centocor

C0743T06

A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in subjects with Relapsing-remitting Multiple Sclerosis. Completed

Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. 

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

Millennium

M120204-063

A Phase 2a Magnetic Resonance Imaging Study 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

Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial.

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 Copaxone

Protocol 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 & Co

Protocol 003-00

A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remtting Multiple Sclerosis as measured by MRI. Terminated -

Abbott

Protocol 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 Study

[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

Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.

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.

Serono

Rebif 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

Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag BM; REGARD study group.

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

GSK

Protocol 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 Extension

3066A2-210-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 -

Wyeth

Protocol 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 -

Gampp

Protocol 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 Haas J, Hommes OR. A dose comparison study of IVIG in postpartum relapsing-remitting multiple sclerosis. Mult Scler. 2007 Aug;13(7):900-8. Epub 2007 Mar 15.

Cannabis

Protocol NoMREC/00/6/05

A multicentre randomised controlled trial of Cannabinoids on spasticity in multiple sclerosis. Completed Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003 Nov 8;362(9395):1517-26.

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-C

BAY 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 study

Serono Study 22930

Long term efficacy and safety phase IV follow up of the Prisms cohort. Completed Kappos L, Traboulsee A, Constantinescu C, Erälinna JP, Forrestal F, Jongen P, Pollard J, Sandberg-Wollheim M, Sindic C, Stubinski B, Uitdehaag B, Li D. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology. 2006 Sep 26;67(6):944-53.

Pharmacogenomic Study

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 Grossman I, Avidan N, Singer C, Goldstaub D, Hayardeny L, Eyal E, Ben-Asher E, Paperna T, Pe'er I, Lancet D, Beckmann JS, Miller A. Pharmacogenetics of glatiramer acetate therapy for multiple sclerosis reveals drug-response markers. Pharmacogenet Genomics. 2007 Aug;17(8):657-66.

MRI Follow-up Study 

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 Polman C, Barkhof F, Sandberg-Wollheim M, Linde A, Nordle O, Nederman T; Laquinimod in Relapsing MS Study Group. Treatment with laquinimod reduces development of active MRI lesions in relapsing MS. Neurology. 2005 Mar 22;64(6):987-91.

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 Miller DH, Khan OA, Sheremata WA, Blumhardt LD, Rice GP, Libonati MA, Willmer-Hulme AJ, Dalton CM, Miszkiel KA, O'Connor PW; International Natalizumab Multiple Sclerosis Trial Group. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2003 Jan 2;348(1):15-23.

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 Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D; PROMiSe Trial Study Group. Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial. Ann Neurol. 2007 Jan;61(1):14-24.

Teva Coral

GA/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 Filippi M, Wolinsky JS, Comi G; CORAL Study Group. Effects of oral glatiramer acetate on clinical and MRI-monitored disease activity in patients with relapsing multiple sclerosis: a multicentre, double-blind, randomised, placebo-controlled study. Lancet Neurol. 2006 Mar;5(3):213-20. Erratum in: Lancet Neurol. 2006 May;5(5):383.

IVIG

BAY 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 Hommes OR, Sørensen PS, Fazekas F, Enriquez MM, Koelmel HW, Fernandez O, Pozzilli C, O'Connor P. Intravenous immunoglobulin in secondary progressive multiple sclerosis: randomised placebo-controlled trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1149-56.

Astra

Protocol 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 Comi G, Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 2001;357:1576-1582.

Cop1 Teva

Protocol 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 European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol. 2001 Mar;49(3):290-7.

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) Study 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

SPECTRIMS

Secondary Progressinv Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group..

 

 

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Clinical Neurology

School of Medicine
The University of Nottingham
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