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

June 2, 2016 updated by: EMD Serono

A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

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]).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Brugge Clinical Site 203
      • La Louviere, Belgium, 8000
        • La Louviere Clinical Site 201
  • Canada
      • Montreal, Canada, H9X3Z9
        • Montreal Clinical Site 102
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Clinical Site 131
    • Quebec
      • Gatineau, Quebec, Canada
        • Gatineau Clinical Site 114
      • Greenfield Park, Quebec, Canada, J4V2J2
        • Greenfield park Clinical Site 109
      • Montreal, Quebec, Canada, H1T2M4
        • Montreal Clinical Site 101
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Olomouc Clinical Site 212
      • Pardubice, Czech Republic, 53203
        • Pardubice Clinical Site 211
      • Praha 5, Czech Republic, 15006
        • Praha 5 Clinical Site 213
  • Germany
      • Glessen, Germany, 35385
        • Glessen Clinical Site 221
      • Leipzig, Germany, 04103
        • Leipzig Clinical Site 229
      • Marburg, Germany, 35033
        • Marburg Clinical Site 228
      • Tubingen, Germany, 72076
        • Tubingen Clinical Site 226
  • Greece
      • Athens, Greece, 115 29
        • Athens Clinical Site 243
  • Japan
      • Kanto, Japan
        • Kanto Region Clinical Site 404
      • Kanto, Japan
        • Kanto Region Clinical Site 405
      • Kanto, Japan
        • Kanto Region Clinical Site 406
      • Kanto, Japan
        • Kanto Region Clinical Site 409
      • Kinki, Japan
        • Kinki Region Clinical Site 401
      • Kinki, Japan
        • Kinki Region Clinical Site 407
      • Kinki, Japan
        • Kinki Region Clinical Site 408
      • Tohoku, Japan
        • Tohoku Region Clinical Site 403
      • Tohoku, Japan
        • Tohoku Region Clinical Site 410
  • Poland
      • Bialystok, Poland, 15-402
        • Bialystok Clinical Site 305
      • Czeladz, Poland, 41-250
        • Czeladz Clinical Site 303
      • Gdansk, Poland, 80-803
        • Gdansk Clinical Site 302
      • Katowice, Poland, 40-594
        • Katowice Clinical Site 309
      • Krakow, Poland, 31-530
        • Krakow Clinical Site 307
      • Lodz, Poland, 90-153
        • Lodz Clinical Site 306
      • Plewiska, Poland, 62-064
        • Plewiska Clinical Site 304
      • Warszawa, Poland, 04-749
        • Warszawa Clinical Site 308
  • Russian Federation
      • Kazan, Russian Federation, 420103
        • Kazan Clinical Site 333
      • Moscow, Russian Federation, 107150
        • Moscow Clinical Site 332
      • Moscow, Russian Federation, 121356
        • Moscow Clinical Site 330
      • Nizhniy Novgorod, Russian Federation, 107150
        • Nizhniy Novgorod Clinical Site 321
      • Novosibirsk, Russian Federation, 630091
        • Novosibirsk Clinical Site 324
      • Samara, Russian Federation, 443095
        • Samara Clinical Site 329
      • St. Petersburg, Russian Federation, 194354
        • St. Petersburg Clinical Site 325
      • Ufa, Russian Federation, 450005
        • Ufa Clinical Site 326
  • Spain
      • Barcelona, Spain, 08025
        • Barcelona Clinical Site 252
      • Barcelona, Spain, 08025
        • Barcelona Clinical Site 253
      • Bilbao, Spain, 48013
        • Bilbao Clinical Site 255
      • Girona, Spain, 17007
        • Girona Clinical Site 254
      • Hospitalet de Llobregat, Spain, 08907
        • Hospitalet de Llobregat Clinical Site 251
      • Sevilla, Spain, 41071
        • Sevilla Clinical Site 256
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49027
        • Dnipropetrovsk Clinical Site 341
      • Kyiv, Ukraine, 03110
        • Kyiv Clinical Site 344
      • Lviv, Ukraine, 03110
        • Lviv Clinical Site 343
      • Vinnytsya, Ukraine, 21005
        • Vinnytsya Clinical Site 342
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85705
        • Tucson Clinical Site 133
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Aurora Clinical Site 132
      • Fort Collins, Colorado, United States, 80528
        • Fort Collins Clinical Site 123
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Fairfield Clinical Site 110
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Ormond Beach Clinical Site 129
      • Sarasota, Florida, United States, 34243
        • Sarasota Clinical Site 116
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Northbrook Clinical Site 135
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Clinical Site 111
      • Indianapolis, Indiana, United States, 46202
        • Indianapolis Clinical Site 121
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Detroit Clinical Site 104
      • Farmington Hills, Michigan, United States, 48334
        • Farmington Hills Clinical Site 126
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Lebanon Clinical Site 115
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Albuquerque Clinical Site 106
    • New York
      • Rochester, New York, United States, 14642
        • Rochester Clinical Site 108
    • North Carolina
      • Charlotte, North Carolina, United States, 28201
        • Charlotte Clinical Site 125
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Clinical Site 103
    • Ohio
      • Akron, Ohio, United States, 44320
        • Akron Clinical Site 112
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Clinical Site 120
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Knoxville Clinical Site 134
    • Texas
      • Round Rock, Texas, United States, 78681
        • Round Rock Clinical Site 107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-4641 0.15 milligram (mg) - 0.15 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Experimental: ONO-4641 0.10 mg - 0.10 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Experimental: ONO-4641 0.05 mg - 0.05 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Experimental: Placebo - ONO4641 0.15 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Experimental: Placebo - ONO4641 0.10 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Experimental: Placebo - ONO4641 0.05 mg
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod
Drug: ONO-4641
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.
Other Names:
  • MSC2430913A
  • Ceralifimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Clinically Significant Abnormal Vital Signs
Time Frame: Baseline up to Week 255
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.
Baseline up to Week 255
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)
Time Frame: Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
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.
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Change From Baseline in Forced Vital Capacity (FVC)
Time Frame: Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
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.
Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
Time Frame: Baseline, Week 40, 52, early termination, Week 152, 200, 255
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.
Baseline, Week 40, 52, early termination, Week 152, 200, 255
Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures
Time Frame: Baseline up to Week 255
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.
Baseline up to Week 255
Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination
Time Frame: Baseline up to Week 255
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).
Baseline up to Week 255
Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination
Time Frame: Baseline up to end of the treatment, assessed up to Week 255
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.
Baseline up to end of the treatment, assessed up to Week 255
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Number of Gadolinium (Gd)-Enhanced Lesions
Time Frame: Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)
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.
Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)
Change From Baseline in Lesion Volume at the End of the Treatment (EoT)
Time Frame: Baseline, End of treatment (5 years)
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.
Baseline, End of treatment (5 years)
Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment
Time Frame: Baseline and at end of treatment (Week 255)
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.
Baseline and at end of treatment (Week 255)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Merck KGaA, Darmstadt, Germany
Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
  • Study Director: Medical Responsible, Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4641POU007 (EMR200559-002)
  • 2010-018705-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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