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Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS)

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fingolimod 1.25 mg
Fingolimod 0.5 mg
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, FTY720, Fingolimod

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis Patients with a relapsing-remitting disease course Patients with EDSS score of 0-5.5 Exclusion Criteria: Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria applied to this study.

Sites / Locations

  • The Queen Elizabeth Hospital
  • North Gosford Private Hospital
  • Strategic Health Evaluators
  • St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
  • Austin Health, Department of Neurology
  • Algemeen Ziekenhuis St. Jan, Department of Neurology
  • Erasme Hospital
  • CHU Charleroi, Hôpital Civil
  • University Hospital Gasthuisberg
  • AZ Alma
  • Regionaal Ziekenhuis
  • MS Klinik
  • National Multiple Sclerose Centrum v.z.w
  • University of British Columbia
  • DMSRU - Capital Health
  • Kingston General Hospital, MS Clinic
  • Nepean Medical Center
  • St. Michael's Hospital
  • Clinical Trials Office,
  • Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
  • University of Saskatchewan
  • Military Hospital of Brno
  • Faculty Hospital St. Anne
  • Faculty Hospital
  • Hospital of Pardubice
  • Faculty Hospital
  • Faculty Hospital Motol, MS Center
  • Vseobecna fakultni nemocnice
  • Neurologicka klinika, Fakultni nemocnice
  • MS Centrum
  • Centrum neurologicke pece
  • Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
  • Helsinki Headache Center Postitalon Lääkäriasema
  • Finnish Special Neurology Center Ltd.
  • Suomen Terveystalo/ Päänsärkykeskus, Tampere
  • Turku University Hospital, Neurology Department 799
  • Hyvinkään sairaala
  • CHU La Timone
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Athens Naval Hospital, Neurology Department
  • Neurology Department Athens General Hospital, G. Gennimatas
  • 1st IKA Papadimitriou Neurology Dept
  • University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
  • Barzilai Medical Center
  • Carmel Medical Center
  • Sieff Medical Center
  • Sheba - Medical Center
  • Kaunas University Hospital Department of Neurology
  • Academisch Ziekenhuis VU
  • St. Antonius Ziekenhuis
  • Multiple Clerosis Center Nijmegen
  • Erasmus MC
  • Sint Elisabeth Ziekenhuis
  • Maaslandziekenhuis Sittard
  • Samodzielny Publiczny Szpital Kliniczny
  • Niezalezny Zespol Opieki Zdrowotnej Kendron
  • Oddzial Neurologiczny i Leczenia Udarow
  • Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
  • Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
  • CSK MSWiA Hospital
  • Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
  • Centralny Szpital Kliniczny, Klinika Neurologii
  • Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
  • Medical University of Lodz
  • Interregional Clinical Diagnistic Center, Neurology Department
  • Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
  • Moscow Regional Research Clinical Institue
  • GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
  • Military Medical Academy, Neurology Department
  • II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
  • Neurologická klinika, Martinská fakultná nemocnica
  • I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
  • Neurologické oddelenie, Nemocnica s poliklinikou Žilina
  • Umhlanga Hospital
  • Division of Neurology, Groote Schuur Hospital
  • Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
  • MS Centrum
  • Karolinska University Hospital Huddinge
  • Karolinska University Hospital, Department of Medicine
  • Kantonsspital Basel, Policlinic
  • Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
  • UniversitätsSpital Zürich, Neurologische Klinik
  • Hacettepe Universiti Hospitals
  • Gazi University
  • EGE University
  • Istanbul University, Istanbul Faculty of Medicine
  • Istanbul University, Cerrahpasa School of Medicine
  • Gaziantep University School of Medicine
  • Uludag University Faculty of Medche
  • Tepecik Training and Research
  • Dokuz University Medical Faculty, Neurology Department
  • Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
  • Mersin Universitesi Tip Fakultesi Hastanesi
  • T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
  • King's College Hospital, Trials office Academie Neuroscience Center
  • Queens Medical Centre
  • Royal Hallamshire Hospital
  • St. George's Hospital, Neurology Dept. Atkinson Morley Wing
  • Frenchay Hospital, Department of Neurology
  • Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fingolimod 1.25 mg

Fingolimod 0.5 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Estimated Annualized Aggregate Relapse Rate (ARR)
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.

Secondary Outcome Measures

Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.

Full Information

First Posted
February 9, 2006
Last Updated
April 9, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00289978
Brief Title
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Acronym
FREEDOMS
Official Title
A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, FTY720, Fingolimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod 1.25 mg
Arm Type
Experimental
Arm Title
Fingolimod 0.5 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fingolimod 1.25 mg
Intervention Description
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5 mg
Intervention Description
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients self-administered a fingolimod placebo capsule orally once daily.
Primary Outcome Measure Information:
Title
Estimated Annualized Aggregate Relapse Rate (ARR)
Description
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.
Time Frame
Baseline to end of study (Month 24)
Secondary Outcome Measure Information:
Title
Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
Description
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Time Frame
Baseline to end of study (Month 24)
Title
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
Description
The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Time Frame
Baseline to end of study (Month 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis Patients with a relapsing-remitting disease course Patients with EDSS score of 0-5.5 Exclusion Criteria: Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria applied to this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
North Gosford Private Hospital
City
Burrabil Avenue, Suite 17, Gosford
ZIP/Postal Code
NSW 2250
Country
Australia
Facility Name
Strategic Health Evaluators
City
Chatswood
ZIP/Postal Code
2067
Country
Australia
Facility Name
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
City
Fitzroy
ZIP/Postal Code
3065 VIC
Country
Australia
Facility Name
Austin Health, Department of Neurology
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Algemeen Ziekenhuis St. Jan, Department of Neurology
City
Ruddershove 10
State/Province
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Erasme Hospital
City
Route de Lennik 808
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Charleroi, Hôpital Civil
City
Boulevard Paul Janson 92
State/Province
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Department Neurology, Herestraat 49
State/Province
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Alma
City
Department of Neurology & Rehab-Umit, Gentsesteenweg 132
State/Province
Sijsele
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Regionaal Ziekenhuis
City
St.Trudo, Diestersteenweg 100,
State/Province
St.Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
MS Klinik
City
Boemerangstraat 2, Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
National Multiple Sclerose Centrum v.z.w
City
Vanheylenstraat 16, Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
University of British Columbia
City
ME498 2211 Wesbrook Mall, Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
DMSRU - Capital Health
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Kingston General Hospital, MS Clinic
City
Connell 7, 76 Stuart Street, Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Nepean Medical Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Clinical Trials Office,
City
Trillium Health Center, 00 Queesway West, Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
University of Saskatchewan
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Military Hospital of Brno
City
Department of Neurology, Zabrdovicka 3
State/Province
Brno
ZIP/Postal Code
63600
Country
Czech Republic
Facility Name
Faculty Hospital St. Anne
City
First Department of Neurology, Pekarska 53
State/Province
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Faculty Hospital
City
Department of Neurology, I.P. Paulova 6
State/Province
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Hospital of Pardubice
City
Department of Neurology, Kyjevska 44
State/Province
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Faculty Hospital
City
Department of Neurology, Alej Svobody 80
State/Province
Plzeň
ZIP/Postal Code
3046
Country
Czech Republic
Facility Name
Faculty Hospital Motol, MS Center
City
Department of Neurology, V Uvalu 84
State/Province
Prague 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice
City
MS Centrum, Neurologicka klinika, Karlovo namesti 32
State/Province
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Neurologicka klinika, Fakultni nemocnice
City
Kralovske Vinohrady, Srobarova 50
State/Province
Praha
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
MS Centrum
City
Neurology Department of Hospital Teplice, Duchcovska 53
State/Province
Teplice
ZIP/Postal Code
41529
Country
Czech Republic
Facility Name
Centrum neurologicke pece
City
Jiraskova 1389, Rychnov nad Kneznou
ZIP/Postal Code
51601
Country
Czech Republic
Facility Name
Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
City
Ostrava
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Helsinki Headache Center Postitalon Lääkäriasema
City
Mannnerheiminaukio 1 B 2 Floor
State/Province
Helsinki
ZIP/Postal Code
0100
Country
Finland
Facility Name
Finnish Special Neurology Center Ltd.
City
Brahenkatu 11 D,
State/Province
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Suomen Terveystalo/ Päänsärkykeskus, Tampere
City
Hämeenkatu 18, 6th fl., Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Turku University Hospital, Neurology Department 799
City
Kiinanmyllynkatu 11- 14, Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hyvinkään sairaala
City
Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää
ZIP/Postal Code
05850
Country
Finland
Facility Name
CHU La Timone
City
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Investigational Site
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Investigational Site
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Investigational Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Investigational Site
City
Munchen
ZIP/Postal Code
80331
Country
Germany
Facility Name
Investigational Site
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Investigational Site
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Investigational Site
City
Seesen/Harz
ZIP/Postal Code
38723
Country
Germany
Facility Name
Investigational Site
City
Stuttgart
ZIP/Postal Code
70191
Country
Germany
Facility Name
Investigational Site
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Investigational Site
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Athens Naval Hospital, Neurology Department
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Neurology Department Athens General Hospital, G. Gennimatas
City
Mesogeion 154 Ave., Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
1st IKA Papadimitriou Neurology Dept
City
Terma Zaimi, Melissia-Athens
ZIP/Postal Code
15127
Country
Greece
Facility Name
University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Sieff Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Sheba - Medical Center
City
Tel Hashomer, Ramat-Gan,
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaunas University Hospital Department of Neurology
City
Eiveniu 2, Kaunas
ZIP/Postal Code
LY-50009
Country
Lithuania
Facility Name
Academisch Ziekenhuis VU
City
De Boelelaan 1118
State/Province
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Postbus 2500
State/Province
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Multiple Clerosis Center Nijmegen
City
Heiweg 97
State/Province
Nyimegen
ZIP/Postal Code
6533
Country
Netherlands
Facility Name
Erasmus MC
City
Dr. Molewaterplein 40
State/Province
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Sint Elisabeth Ziekenhuis
City
Hilvarenbeekse Weg 60
State/Province
Tilburg
ZIP/Postal Code
5022
Country
Netherlands
Facility Name
Maaslandziekenhuis Sittard
City
Walramstraat 23, BK Sittard
ZIP/Postal Code
6131
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny
City
Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A
State/Province
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Niezalezny Zespol Opieki Zdrowotnej Kendron
City
Ul. Swietego Mikolaja 1/8
State/Province
Bialystok
ZIP/Postal Code
15-420
Country
Poland
Facility Name
Oddzial Neurologiczny i Leczenia Udarow
City
Mozgu, Nowe Ogrody 1/6
State/Province
Gdańsk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
City
ul. Medykow 14
State/Province
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
City
Department of Neurology, ul. Przybyszewskiego 49
State/Province
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
CSK MSWiA Hospital
City
Department of Neurology, Wołoska 137
State/Province
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
City
II Klinika Neurologii, ul. Sobieskiego 1/9
State/Province
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Centralny Szpital Kliniczny, Klinika Neurologii
City
MSWiAw Warszawie, Woloska 137
State/Province
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
City
ul. Banacha 1A
State/Province
Warszawa
ZIP/Postal Code
01-097
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
Country
Poland
Facility Name
Interregional Clinical Diagnistic Center, Neurology Department
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Moscow Regional Research Clinical Institue
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
City
St-Petersburg
Country
Russian Federation
Facility Name
Military Medical Academy, Neurology Department
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
City
Limbová 5
State/Province
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Neurologická klinika, Martinská fakultná nemocnica
City
Kollárova 2, Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
City
Mickiewiczova 13, Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Neurologické oddelenie, Nemocnica s poliklinikou Žilina
City
ul.V. Spanyola 43, Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Umhlanga Hospital
City
Umhlanga
State/Province
KZN
ZIP/Postal Code
4319
Country
South Africa
Facility Name
Division of Neurology, Groote Schuur Hospital
City
E 8-74, Groote Schuur Hospital, Observatory Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
City
Sandton
ZIP/Postal Code
2196
Country
South Africa
Facility Name
MS Centrum
City
Forskningsenhet, SU/Östra CKÖ plan 0
State/Province
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Department Of Neurology R54, Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Karolinska University Hospital, Department of Medicine
City
Neuroimmunology unit, CMM L8:04, Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Kantonsspital Basel, Policlinic
City
Neurology-Neurosurgical, Petersgraben 4
State/Province
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
City
Rue du Bugnon
State/Province
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitätsSpital Zürich, Neurologische Klinik
City
Frauenklinikstr. 26, Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Hacettepe Universiti Hospitals
City
Department of Neurology
State/Province
Ankara
Country
Turkey
Facility Name
Gazi University
City
Medical Faculty Neurology Department
State/Province
Besevler Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
EGE University
City
Medical Faculty Hospital Neurolgy Department
State/Province
Bornova Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Departement of Neurology
State/Province
Capa Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University, Cerrahpasa School of Medicine
City
Department of Neurology
State/Province
Cerrahpasa Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Gaziantep University School of Medicine
City
Neurology Department
State/Province
Gaziantep
ZIP/Postal Code
27070
Country
Turkey
Facility Name
Uludag University Faculty of Medche
City
Tip Fakultesi, Noroloji ABD
State/Province
Görükle / Bursa
Country
Turkey
Facility Name
Tepecik Training and Research
City
Hospital Neurology Service, 35120 Gaziler Cad. Izmir
Country
Turkey
Facility Name
Dokuz University Medical Faculty, Neurology Department
City
Inciralti, Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Mersin Universitesi Tip Fakultesi Hastanesi
City
Noroloji ABD, Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
City
Noroloji Klinigi, Göztepe Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
King's College Hospital, Trials office Academie Neuroscience Center
City
P041 Institute of Psychiatry, Denmark Hill
State/Province
London
ZIP/Postal Code
SES 8AF
Country
United Kingdom
Facility Name
Queens Medical Centre
City
Division of Clinical Neurology Medical School
State/Province
Nottingham
ZIP/Postal Code
NG7 24H
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Glossop Road
State/Province
Sheffield
ZIP/Postal Code
S102JF
Country
United Kingdom
Facility Name
St. George's Hospital, Neurology Dept. Atkinson Morley Wing
City
Backshaw Road, London
ZIP/Postal Code
Tooting London SW17 0QT
Country
United Kingdom
Facility Name
Frenchay Hospital, Department of Neurology
City
Beckspool Road, Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Queen Victoria Road, Newcastle-upon-Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35698787
Citation
Nowak CP, Mutze T, Konietschke F. Group sequential methods for the Mann-Whitney parameter. Stat Methods Med Res. 2022 Oct;31(10):2004-2020. doi: 10.1177/09622802221107103. Epub 2022 Jun 13.
Results Reference
derived
PubMed Identifier
27733070
Citation
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Results Reference
derived
PubMed Identifier
26121423
Citation
Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.
Results Reference
derived
PubMed Identifier
25876471
Citation
Kremenchutzky M, O'Connor P, Hohlfeld R, Zhang-Auberson L, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Kappos L. Impact of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod: Subgroup analyses of the Fingolimod Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study. Mult Scler Relat Disord. 2014 May;3(3):341-9. doi: 10.1016/j.msard.2013.10.006. Epub 2013 Nov 5.
Results Reference
derived
PubMed Identifier
25245812
Citation
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.
Results Reference
derived
PubMed Identifier
23531349
Citation
Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
Results Reference
derived
PubMed Identifier
22751847
Citation
Radue EW, O'Connor P, Polman CH, Hohlfeld R, Calabresi P, Selmaj K, Mueller-Lenke N, Agoropoulou C, Holdbrook F, de Vera A, Zhang-Auberson L, Francis G, Burtin P, Kappos L; FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) Study Group. Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Arch Neurol. 2012 Oct;69(10):1259-69. doi: 10.1001/archneurol.2012.1051.
Results Reference
derived
PubMed Identifier
22494956
Citation
Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C, Haring DA, Francis G, Kappos L; FREEDOMS study group. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012 May;11(5):420-8. doi: 10.1016/S1474-4422(12)70056-X. Epub 2012 Apr 10. Erratum In: Lancet Neurol. 2012 Aug;11(8):658.
Results Reference
derived
PubMed Identifier
20089952
Citation
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. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. doi: 10.1056/NEJMoa0909494. Epub 2010 Jan 20.
Results Reference
derived
Links:
URL
http://www.msclinicaltrials.com
Description
Fingolimod clinical trials information website

Learn more about this trial

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

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