A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— DreaMS  

Official title:

A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081782
• Other study ID #: ONO-4641POU006
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2010
• Last updated: November 30, 2013
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2013
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaBelgium: Federal Agency for Medicinal Products and Health ProductsJapan: Ministry of Health, Labor and WelfareGreece: National Organization of MedicinesSpain: Ministry of HealthCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesUkraine: Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adult male or female aged 18-55 years inclusive at screening

• Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

Exclusion Criteria:

• Multiple Sclerosis course other than relapsing-remitting multiple sclerosis

• History of malignancy

• History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)

• Inability to undergo Gd-enhanced MRI scans

• Diagnosis of diabetes mellitus (type I or type II)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, 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
0.15 mg once per day for 26 weeks
• ONO-4641
0.1 mg once per day for 26 weeks
• ONO-4641
0.05 mg once per day for 26 weeks
• ONO-4641 placebo
Placebo once per day for 26 weeks

Locations

Country	Name	City	State
Belgium	Brugge Clinical Site 203	Brugge
Belgium	La Louviere Clinical Site 201	La Louviere
Belgium	Sijsele Clinical Site 202	Sijsele
Canada	Vancouver Clinical Site 131	British Columbia
Canada	Gatineau Clinical Site 114	Gatineau	Quebec
Canada	Greenfield Park Clinical Site 109	Greenfield Park	Quebec
Canada	Montreal Clinical Site 102	Quebec
Canada	Montreal Clinical Site 113	Quebec
Czech Republic	Olomouc Clinical Site 212	Olomouc
Czech Republic	Ostrava Clinical Site 214	Ostrava
Czech Republic	Pardubice Clinical Site 211	Pardubice
Czech Republic	Praha 5 Clinical Site 213	Praha 5
Germany	Berlin Clinical Site 223	Berlin
Germany	Essen Clinical Site 222	Essen
Germany	Giessen Clinical Site 221	Giessen
Germany	Leipzig Clinical Site 229	Leipzig
Germany	Mainz Clinical Site 231	Mainz
Germany	Marburg Clinical Site 228	Marburg
Germany	Munster Clinical Site 225	Munster
Germany	Tubingen Clinical Site 226	Tubingen
Germany	Ulm Clinical Site 230	Ulm
Greece	Athens Clinical Site 243	Athens
Greece	Thessaloniki Clinical Site 245	Thessaloniki
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	Chelyabinsk Clinical Site 322	Chelyabinsk
Russian Federation	Kaluga Clinical Site 328	Kaluga
Russian Federation	Kazan Clinical Site 333	Kazan
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 328	Samara
Russian Federation	St. Petersburg Clinical Site 325	St. Petersburg
Russian Federation	St. Petersburg Clinical Site 327	St. Petersburg
Russian Federation	Ufa Clinical Site 326	Ufa
Russian Federation	Yaroslavl Clinical Site 331	Yaroslavl
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	Donetsk Clinical Site 345	Donetsk
Ukraine	Kharkiv Clinical Site 346	Kharkiv
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 Clinical 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	HighPoint Clinical Site 128	HighPoint	North Carolina
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	Sarasota Clinical Site 117	Sarasota	Florida
United States	Seattle Clinical Site 118	Seattle	Washington
United States	Tucson Clinical Site 133	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.		26 weeks	No
Secondary	Total volume of Gd-enhanced lesions		26 weeks	No