Fty720d    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica73

13. Multiple sclerosis/Neuromyelitis optica    [ 3,050 clinical trials,   2,147 drugs,   (DrugBank: 348 drugs),   244 drug target genes,   228 drug target pathways]
Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
73 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-002660-17-DK
(EUCTR)
02/06/201516/04/2015Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosisLong-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolmod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
281Phase 2Portugal;France;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland
2EUCTR2013-002660-17-PT
(EUCTR)
02/01/201514/11/2014Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosisLong-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolmod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
281Phase 2France;Portugal;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland
3EUCTR2013-002660-17-IT
(EUCTR)
09/04/201417/02/2014Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosisLong-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolmod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
281Phase 2France;Portugal;Canada;Finland;Spain;Poland;Denmark;Germany;United Kingdom;Switzerland;Italy
4EUCTR2012-000835-18-CZ
(EUCTR)
27/09/201317/06/2013A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 16.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
5EUCTR2012-000835-18-NL
(EUCTR)
19/03/201303/01/2013A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-000835-18-GB
(EUCTR)
18/03/201309/11/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
7EUCTR2012-000835-18-ES
(EUCTR)
23/01/201329/11/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GYLENIA 0,5 mg
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Farmaceutica S.A.NULLNot RecruitingFemale: yes
Male: yes
750United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden
8EUCTR2012-000835-18-BE
(EUCTR)
18/01/201319/11/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
750United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Sweden
9EUCTR2012-000835-18-IT
(EUCTR)
12/01/201319/12/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 Primary progressive multiple sclerosis.
MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
750United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Sweden
10EUCTR2012-000835-18-FR
(EUCTR)
20/12/201219/06/2013A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
700Phase 3United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-000835-18-FI
(EUCTR)
28/11/201208/11/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
12EUCTR2012-000835-18-SE
(EUCTR)
07/11/201201/10/2012A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, 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 - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
13EUCTR2011-000770-60-IT
(EUCTR)
12/04/201101/09/2011An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - NDAn open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: other nervous system drugs
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
600Italy
14EUCTR2010-024017-31-IT
(EUCTR)
15/03/201108/02/2011A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDENA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta-1b
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
Italy
15EUCTR2010-020515-37-DK
(EUCTR)
14/02/201103/01/2011A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. - Relapsing multiple sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Estonia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-019029-32-SK
(EUCTR)
27/01/201112/05/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden
17EUCTR2010-020515-37-IE
(EUCTR)
04/01/201113/10/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
18EUCTR2010-020515-37-CZ
(EUCTR)
03/01/201127/07/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Romania;Norway;Germany;Sweden;Poland;Belgium;Brazil
19EUCTR2010-023023-19-IT
(EUCTR)
28/12/201019/11/2010A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - NDA 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - ND relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta-1b
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
Germany;Italy
20EUCTR2010-020515-37-BE
(EUCTR)
17/12/201028/10/2010Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Greece;Spain;Costa Rica;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-020515-37-NL
(EUCTR)
01/12/201012/10/2010long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing multiple sclerosis. Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Portugal;Comoros;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria
22EUCTR2007-002627-32-DK
(EUCTR)
29/11/201020/10/2010A study to evaluate how safe and effective 0.5 mg fingolimod is in delaying disability progression if taken once daily, in patients with PPMSA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
970United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
23EUCTR2010-020515-37-IT
(EUCTR)
25/10/201014/09/2010A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND MS (MULTIPLE SCLEROSIS)
MedDRA version: 9.1;Level: LLT;Classification code 10048393
Product Name: fingolimod
Product Code: FTY720D
NOVARTIS FARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Estonia;Spain;Greece
24EUCTR2010-020515-37-AT
(EUCTR)
21/10/201015/09/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
25EUCTR2010-020515-37-ES
(EUCTR)
20/10/201002/08/2010Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltipleEstudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple Esclerosis Múltiple Remitente Recurrente
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-020515-37-SK
(EUCTR)
18/10/201003/08/2010A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
27EUCTR2010-019028-30-BE
(EUCTR)
08/10/201017/08/2010A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. Relapsing forms of multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120France;Finland;Spain;Belgium;United Kingdom
28EUCTR2010-020515-37-EE
(EUCTR)
08/10/201009/09/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (LONGTERMS). multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Ireland;Portugal;United States;Estonia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
29EUCTR2010-019029-32-BE
(EUCTR)
08/10/201003/08/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Phase 2Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
30EUCTR2010-020515-37-GR
(EUCTR)
05/10/201004/10/2010A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2010-020515-37-HU
(EUCTR)
30/09/201011/08/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
32EUCTR2010-020515-37-SE
(EUCTR)
27/09/201024/08/2010Long-term safety, tolerability and efficacy study of 0.5 mg fingolimodonce daily in patients with multiple sclerosis.A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. Multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
33EUCTR2010-019028-30-FR
(EUCTR)
03/09/201009/07/2010A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. Relapsing forms of multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120France;Finland;Belgium;Spain;United Kingdom
34EUCTR2010-019029-32-CZ
(EUCTR)
02/09/201008/06/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Hungary;Denmark;Germany;Netherlands;Sweden
35EUCTR2010-020515-37-FI
(EUCTR)
06/08/201024/06/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2010-019029-32-NL
(EUCTR)
05/08/201007/06/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1350Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
37EUCTR2010-019029-32-DK
(EUCTR)
02/08/201025/06/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
38EUCTR2010-019028-30-GB
(EUCTR)
30/07/201002/08/2010A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. Relapsing forms of multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Finland;United Kingdom;France;Spain
39EUCTR2010-019029-32-AT
(EUCTR)
28/07/201008/06/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
40EUCTR2010-019029-32-HU
(EUCTR)
21/07/201031/03/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1850Italy;Austria;Hungary;Portugal;Germany;Netherlands;Sweden;Ireland;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2010-019029-32-GR
(EUCTR)
19/07/201014/07/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
42EUCTR2010-019029-32-IE
(EUCTR)
19/07/201018/05/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1850Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
43EUCTR2010-019029-32-SE
(EUCTR)
12/07/201025/05/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
44EUCTR2010-019029-32-FI
(EUCTR)
07/07/201028/05/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
45EUCTR2010-019028-30-FI
(EUCTR)
07/07/201027/05/2010A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. Relapsing forms of multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Finland;United Kingdom;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2010-019029-32-PT
(EUCTR)
31/05/201007/05/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1850Portugal;Hungary;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
47EUCTR2010-019029-32-GB
(EUCTR)
07/05/201016/04/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
48EUCTR2010-019029-32-DE
(EUCTR)
06/05/201002/03/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
2400Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden
49EUCTR2010-019029-32-IT
(EUCTR)
27/04/201009/04/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - NDA 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND MS (MULTIPLE SCLEROSIS)
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
50EUCTR2007-002627-32-HU
(EUCTR)
31/03/201005/02/2010A double-blind, randomized, multicenter, placebocontrolled, 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.A double-blind, randomized, multicenter, placebocontrolled, 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. Primary progressive multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
940France;Czech Republic;Hungary;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2007-004122-24-HU
(EUCTR)
23/04/200916/02/2009An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Sweden
52EUCTR2007-004122-24-FI
(EUCTR)
08/04/200904/06/2008An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
53EUCTR2008-002096-27-AT
(EUCTR)
19/03/200909/07/2008A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/AA 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1080Phase -United Kingdom;Poland;Austria;Lithuania
54EUCTR2007-002627-32-CZ
(EUCTR)
04/02/200909/04/2008efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. Primary progressive multiple sclerosis.
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
970Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;Germany;Sweden
55EUCTR2007-004122-24-GR
(EUCTR)
13/01/200930/01/2009An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2008-002096-27-LT
(EUCTR)
22/12/200816/07/2008A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/AA 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1080United Kingdom;Austria;Poland;Lithuania
57EUCTR2008-002096-27-GB
(EUCTR)
28/11/200814/10/2008A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/AA 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1080United Kingdom;Austria;Poland;Lithuania
58EUCTR2007-002627-32-NL
(EUCTR)
31/10/200811/07/2008A clinical study in which the efficacy and safety of 0.5 mg FTY720 versus placebo is evaluated vluated in patients with primary progressive multiple sclerosis.A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
970United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
59EUCTR2008-002096-27-PL
(EUCTR)
10/09/200825/06/2008A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/AA 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A Relapsing-remitting multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1080United Kingdom;Austria;Poland;Lithuania
60EUCTR2007-004122-24-FR
(EUCTR)
21/08/200803/06/2008An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-002627-32-BE
(EUCTR)
08/08/200820/08/2008A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMSA double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary Primary progressive multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
970United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
62EUCTR2007-002627-32-FR
(EUCTR)
05/08/200809/05/2008A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. Primary progressive multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
650Phase 3France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
63EUCTR2007-002627-32-ES
(EUCTR)
17/07/200808/05/2008Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresivaEstudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva Esclerosis múltiple primaria progresiva.
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
650France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
64EUCTR2007-002627-32-SE
(EUCTR)
12/06/200828/04/2008A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMSA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - Efficacy and safety of 0.5 mg fingolimod in patients with PPMS Primary progressive multiple sclerosis.
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Services Pharma AGNULLNot RecruitingFemale: yes
Male: yes
970France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
65EUCTR2007-002627-32-IT
(EUCTR)
11/06/200816/05/2008A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - NDA double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND primary progressive multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: fingolimod
Product Code: FTY720D
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
650France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2007-002627-32-FI
(EUCTR)
05/06/200822/04/2008A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
940United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
67EUCTR2007-004122-24-CZ
(EUCTR)
30/04/200803/01/2008An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
68EUCTR2007-004122-24-NL
(EUCTR)
26/03/200828/02/2008An extension of the 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.An extension of the 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. Relapsing-remitting multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
69EUCTR2007-004122-24-BE
(EUCTR)
21/03/200813/02/2008An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
70EUCTR2005-000365-19-HU
(EUCTR)
25/01/200722/09/2006A 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.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. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Finland;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2006-000704-17-IT
(EUCTR)
15/09/200606/11/2009A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 Relapsing-remitting multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10028245
Product Name: fingolimod
Product Code: FTY720D
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: Interferon beta-1a
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
72EUCTR2005-000365-19-CZ
(EUCTR)
02/02/200611/01/2006A 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.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. Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1250Hungary;Finland;Germany;United Kingdom;Czech Republic;Estonia;Ireland;Greece;Lithuania;Sweden
73EUCTR2007-002627-32-DE
(EUCTR)
26/05/2008A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Gilenya 0,5 mg Hartkapseln
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
970United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden