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

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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

External Links

•   Trial Abstract