Clinical Trials Logo
  1. Home
  2. Multiple Sclerosis
  3. NCT01226745
  4. Details
NCT01226745 Clinical Trial

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

Multiple Sclerosis Clinical Trial

— DreaMS  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01226745
Other study ID # ONO-4641POU007 (EMR200559-002)
Secondary ID 2010-018705-11
Status Terminated
Phase Phase 2
First received October 19, 2010
Last updated July 15, 2015
Start date October 2010
Est. completion date December 2014

Study information
Verified date July 2015
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthSpain: Ministry of HealthJapan: Ministry of Health, Labor and WelfareGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 343
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-4641 (MSC2430913A)
0.15 mg once per day for 225 weeks
• ONO-4641 (MSC2430913A)
0.1 mg once per day for 225 weeks
• ONO-4641 (MSC2430913A)
0.05 mg once per day for 225 weeks

Locations
Country Name City State
Belgium Brugge Clinical Site 203 Brugge
Belgium La Louviere Clinical Site 201 La Louviere
Canada Gatineau Clinical Site 114 Gatineau Quebec
Canada Greenfield park Clinical Site 109 Greenfield Park Quebec
Canada Montreal Clinical Site 101 Montreal Quebec
Canada Montreal Clinical Site 102 Montreal
Canada Vancouver Clinical Site 131 Vancouver British Columbia
Czech Republic Olomouc Clinical Site 212 Olomouc
Czech Republic Pardubice Clinical Site 211 Pardubice
Czech Republic Praha 5 Clinical Site 213 Praha 5
Germany Glessen Clinical Site 221 Glessen
Germany Leipzig Clinical Site 229 Leipzig
Germany Marburg Clinical Site 228 Marburg
Germany Tubingen Clinical Site 226 Tubingen
Greece Athens Clinical Site 243 Athens
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 Kanto
Japan Kinki Region Clinical Site 401 Kinki
Japan Kinki Region Clinical Site 407 Kinki
Japan Kinki Region Clinical Site 408 Kinki
Japan Tohoku Region Clinical Site 403 Tohoku
Japan Tohoku Region Clinical Site 410 Tohoku
Poland Bialystok Clinical Site 305 Bialystok
Poland Czeladz Clinical Site 303 Czeladz
Poland Gdansk Clinical Site 302 Gdansk
Poland Katowice Clinical Site 309 Katowice
Poland Krakow Clinical Site 307 Krakow
Poland Lodz Clinical Site 306 Lodz
Poland Plewiska Clinical Site 304 Plewiska
Poland Warszawa Clinical Site 308 Warszawa
Russian Federation Kazan Clinical Site 333 Kazan
Russian Federation Moscow Clinical Site 330 Moscow
Russian Federation Moscow Clinical Site 332 Moscow
Russian Federation Nizhniy Novgorod Clinical Site 321 Nizhniy Novgorod
Russian Federation Novosibirsk Clinical Site 324 Novosibirsk
Russian Federation Samara Clinical Site 329 Samara
Russian Federation St. Petersburg Clinical Site 325 St. Petersburg
Russian Federation Ufa Clinical Site 326 Ufa
Spain Barcelona Clinical Site 252 Barcelona
Spain Barcelona Clinical Site 253 Barcelona
Spain Bilbao Clinical Site 255 Bilbao
Spain Girona Clinical Site 254 Girona
Spain Hospitalet de Llobregat Clinical Site 251 Hospitalet de Llobregat
Spain Sevilla Clinical Site 256 Sevilla
Ukraine Dnipropetrovsk Clinical Site 341 Dnipropetrovsk
Ukraine Kyiv Clinical Site 344 Kyiv
Ukraine Lviv Clinical Site 343 Lviv
Ukraine Vinnytsya Clinical Site 342 Vinnytsya
United States Akron Clinical Site 112 Akron Ohio
United States Albuquerque Clinical Site 106 Albuquerque New Mexico
United States Aurora Clinical Site 132 Aurora Colorado
United States Charlotte Clinical Site 125 Charlotte North Carolina
United States Detroit Clinical Site 104 Detroit Michigan
United States Fairfield Clincial Site 110 Fairfield Connecticut
United States Farmington Hills Clinical Site 126 Farmington Hills Michigan
United States Fort Collins Clinical Site 123 Fort Collins Colorado
United States Fort Wayne Clinical Site 111 Fort Wayne Indiana
United States Indianapolis Clinical Site 121 Indianapolis Indiana
United States Knoxville Clinical Site 134 Knoxville Tennessee
United States Lebanon Clinical Site 115 Lebanon New Hampshire
United States Northbrook Clinical Site 135 Northbrook Illinois
United States Ormond Beach Clinical Site 129 Ormond Beach Florida
United States Philadelphia Clinical Site 120 Philadelphia Pennsylvania
United States Raleigh Clinical Site 103 Raleigh North Carolina
United States Rochester Clinical Site 108 Rochester New York
United States Round Rock Clinical Site 107 Round Rock Texas
United States Sarasota Clinical Site 116 Sarasota Florida
United States Tucson Clinical Site 133 Tucson Arizona

Sponsors (3)
Lead Sponsor Collaborator
EMD Serono Merck KGaA, Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Germany,  Greece,  Japan,  Poland,  Russian Federation,  Spain,  Ukraine, 

References & Publications (1)

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, Ma

Outcome
Type Measure Description Time frame Safety issue
Primary The long-term safety and tolerability of ONO-4641 (MSC2430913A) using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations 229 weeks Yes
Secondary The number of Gd-enhanced lesions obtained by MRI 229 weeks Yes
Secondary Lesion volume obtained by MRI 229 weeks Yes
Secondary Brain volume obtained by MRI 229 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4

External Links