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Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) (DreaMS)

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-4641
ONO-4641
ONO-4641
ONO-4641
ONO-4641
ONO-4641
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, ONO-4641, MSC2430913A, Efficacy

Eligibility Criteria

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

Inclusion Criteria:

  • Completed 26 weeks of double-blind phase of Study ONO-4641POU006

Exclusion Criteria:

  • Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer

Sites / Locations

  • Tucson Clinical Site 133
  • Aurora Clinical Site 132
  • Fort Collins Clinical Site 123
  • Fairfield Clinical Site 110
  • Ormond Beach Clinical Site 129
  • Sarasota Clinical Site 116
  • Northbrook Clinical Site 135
  • Fort Wayne Clinical Site 111
  • Indianapolis Clinical Site 121
  • Detroit Clinical Site 104
  • Farmington Hills Clinical Site 126
  • Lebanon Clinical Site 115
  • Albuquerque Clinical Site 106
  • Rochester Clinical Site 108
  • Charlotte Clinical Site 125
  • Raleigh Clinical Site 103
  • Akron Clinical Site 112
  • Philadelphia Clinical Site 120
  • Knoxville Clinical Site 134
  • Round Rock Clinical Site 107
  • Brugge Clinical Site 203
  • La Louviere Clinical Site 201
  • Vancouver Clinical Site 131
  • Gatineau Clinical Site 114
  • Greenfield park Clinical Site 109
  • Montreal Clinical Site 101
  • Montreal Clinical Site 102
  • Olomouc Clinical Site 212
  • Pardubice Clinical Site 211
  • Praha 5 Clinical Site 213
  • Glessen Clinical Site 221
  • Leipzig Clinical Site 229
  • Marburg Clinical Site 228
  • Tubingen Clinical Site 226
  • Athens Clinical Site 243
  • Kanto Region Clinical Site 404
  • Kanto Region Clinical Site 405
  • Kanto Region Clinical Site 406
  • Kanto Region Clinical Site 409
  • Kinki Region Clinical Site 401
  • Kinki Region Clinical Site 407
  • Kinki Region Clinical Site 408
  • Tohoku Region Clinical Site 403
  • Tohoku Region Clinical Site 410
  • Bialystok Clinical Site 305
  • Czeladz Clinical Site 303
  • Gdansk Clinical Site 302
  • Katowice Clinical Site 309
  • Krakow Clinical Site 307
  • Lodz Clinical Site 306
  • Plewiska Clinical Site 304
  • Warszawa Clinical Site 308
  • Kazan Clinical Site 333
  • Moscow Clinical Site 332
  • Moscow Clinical Site 330
  • Nizhniy Novgorod Clinical Site 321
  • Novosibirsk Clinical Site 324
  • Samara Clinical Site 329
  • St. Petersburg Clinical Site 325
  • Ufa Clinical Site 326
  • Barcelona Clinical Site 252
  • Barcelona Clinical Site 253
  • Bilbao Clinical Site 255
  • Girona Clinical Site 254
  • Hospitalet de Llobregat Clinical Site 251
  • Sevilla Clinical Site 256
  • Dnipropetrovsk Clinical Site 341
  • Kyiv Clinical Site 344
  • Lviv Clinical Site 343
  • Vinnytsya Clinical Site 342

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ONO-4641 0.15 milligram (mg) - 0.15 mg

ONO-4641 0.10 mg - 0.10 mg

ONO-4641 0.05 mg - 0.05 mg

Placebo - ONO4641 0.15 mg

Placebo - ONO4641 0.10 mg

Placebo - ONO4641 0.05 mg

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Clinically Significant Abnormal Vital Signs
Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)
FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Change From Baseline in Forced Vital Capacity (FVC)
FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO "% of predicted" was defined as the mean value of 2 test results that were within a 10% variability of each other.
Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures
The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.
Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination
Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).
Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination
A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

Number of Gadolinium (Gd)-Enhanced Lesions
Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.
Change From Baseline in Lesion Volume at the End of the Treatment (EoT)
Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study - extension baseline value.
Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment
Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.

Full Information

First Posted
October 19, 2010
Last Updated
June 2, 2016
Sponsor
EMD Serono
Collaborators
Merck KGaA, Darmstadt, Germany, Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01226745
Brief Title
Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
Acronym
DreaMS
Official Title
A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Merck has decided to not pursue phase 3 development of ceralifimod (ONO-4641). The decision was not related to any safety and efficacy findings
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
Collaborators
Merck KGaA, Darmstadt, Germany, Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, ONO-4641, MSC2430913A, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONO-4641 0.15 milligram (mg) - 0.15 mg
Arm Type
Experimental
Arm Title
ONO-4641 0.10 mg - 0.10 mg
Arm Type
Experimental
Arm Title
ONO-4641 0.05 mg - 0.05 mg
Arm Type
Experimental
Arm Title
Placebo - ONO4641 0.15 mg
Arm Type
Experimental
Arm Title
Placebo - ONO4641 0.10 mg
Arm Type
Experimental
Arm Title
Placebo - ONO4641 0.05 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Other Intervention Name(s)
MSC2430913A, Ceralifimod
Intervention Description
Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Primary Outcome Measure Information:
Title
Number of Subjects With Clinically Significant Abnormal Vital Signs
Description
Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.
Time Frame
Baseline up to Week 255
Title
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)
Description
FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Time Frame
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Time Frame
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Title
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
Description
DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO "% of predicted" was defined as the mean value of 2 test results that were within a 10% variability of each other.
Time Frame
Baseline, Week 40, 52, early termination, Week 152, 200, 255
Title
Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures
Description
The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.
Time Frame
Baseline up to Week 255
Title
Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination
Description
Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).
Time Frame
Baseline up to Week 255
Title
Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination
Description
A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.
Time Frame
Baseline up to end of the treatment, assessed up to Week 255
Title
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
Description
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Number of Gadolinium (Gd)-Enhanced Lesions
Description
Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.
Time Frame
Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)
Title
Change From Baseline in Lesion Volume at the End of the Treatment (EoT)
Description
Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study - extension baseline value.
Time Frame
Baseline, End of treatment (5 years)
Title
Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment
Description
Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.
Time Frame
Baseline and at end of treatment (Week 255)

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: Completed 26 weeks of double-blind phase of Study ONO-4641POU006 Exclusion Criteria: Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Tucson Clinical Site 133
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Aurora Clinical Site 132
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Fort Collins Clinical Site 123
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Fairfield Clinical Site 110
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Ormond Beach Clinical Site 129
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sarasota Clinical Site 116
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Northbrook Clinical Site 135
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Fort Wayne Clinical Site 111
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Indianapolis Clinical Site 121
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Detroit Clinical Site 104
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Farmington Hills Clinical Site 126
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Lebanon Clinical Site 115
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Site 106
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Rochester Clinical Site 108
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Charlotte Clinical Site 125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28201
Country
United States
Facility Name
Raleigh Clinical Site 103
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Akron Clinical Site 112
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Philadelphia Clinical Site 120
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Knoxville Clinical Site 134
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Round Rock Clinical Site 107
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Brugge Clinical Site 203
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
La Louviere Clinical Site 201
City
La Louviere
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Vancouver Clinical Site 131
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Gatineau Clinical Site 114
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Greenfield park Clinical Site 109
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2J2
Country
Canada
Facility Name
Montreal Clinical Site 101
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Facility Name
Montreal Clinical Site 102
City
Montreal
ZIP/Postal Code
H9X3Z9
Country
Canada
Facility Name
Olomouc Clinical Site 212
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Pardubice Clinical Site 211
City
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Praha 5 Clinical Site 213
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Glessen Clinical Site 221
City
Glessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Leipzig Clinical Site 229
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Marburg Clinical Site 228
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Tubingen Clinical Site 226
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Athens Clinical Site 243
City
Athens
ZIP/Postal Code
115 29
Country
Greece
Facility Name
Kanto Region Clinical Site 404
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 405
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 406
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 409
City
Kanto
Country
Japan
Facility Name
Kinki Region Clinical Site 401
City
Kinki
Country
Japan
Facility Name
Kinki Region Clinical Site 407
City
Kinki
Country
Japan
Facility Name
Kinki Region Clinical Site 408
City
Kinki
Country
Japan
Facility Name
Tohoku Region Clinical Site 403
City
Tohoku
Country
Japan
Facility Name
Tohoku Region Clinical Site 410
City
Tohoku
Country
Japan
Facility Name
Bialystok Clinical Site 305
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Czeladz Clinical Site 303
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Gdansk Clinical Site 302
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Katowice Clinical Site 309
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Krakow Clinical Site 307
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Lodz Clinical Site 306
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Plewiska Clinical Site 304
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Warszawa Clinical Site 308
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Kazan Clinical Site 333
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
Moscow Clinical Site 332
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Moscow Clinical Site 330
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Nizhniy Novgorod Clinical Site 321
City
Nizhniy Novgorod
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Novosibirsk Clinical Site 324
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Samara Clinical Site 329
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
St. Petersburg Clinical Site 325
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Ufa Clinical Site 326
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Barcelona Clinical Site 252
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Barcelona Clinical Site 253
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Bilbao Clinical Site 255
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Girona Clinical Site 254
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospitalet de Llobregat Clinical Site 251
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Sevilla Clinical Site 256
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Dnipropetrovsk Clinical Site 341
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Kyiv Clinical Site 344
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Lviv Clinical Site 343
City
Lviv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Vinnytsya Clinical Site 342
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
Citation
Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161) Amit Bar-Or, Frauke Zipp, Matthew Scaramozza, Timothy Vollmer, Bryan Due, Karthinathan Thangavelu, Tanya Fischer, and Krzysztof Selmaj April 8, 2014 82:10 Supplement P3.161; 1526-632X
Results Reference
result
Links:
URL
http://www.neurology.org/content/82/10_Supplement/P3.161.abstract
Description
Trial Abstract

Learn more about this trial

Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

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