Multiple SclerosisPhase 2DreaMSNCT01081782
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing ONO-4641 in people with Multiple Sclerosis, run by Ono Pharma USA Inc at 86 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ONO-4641
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 86 sitesin 11 countries
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult male or female aged 18-55 years inclusive at screening
- Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis
Who cannot join
- 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)
Trial locations and contacts
86 sites in 11 countries.
86 sites in 11 countries
United States23 sites
Akron Clinical Site 112
Akron, Ohio, 44320
Albuquerque Clinical Site 106
Albuquerque, New Mexico, 87131
Aurora Clinical Site 132
Aurora, Colorado, 80045
Charlotte Clinical Site 125
Charlotte, North Carolina, 28204
Detroit Clinical Site 104
Detroit, Michigan, 48202
Fairfield Clinical Site 110
Fairfield, Connecticut, 06824
Farmington Hills Clinical Site 126
Farmington Hills, Michigan, 48334
Fort Collins Clinical Site 123
Fort Collins, Colorado, 80528
Fort Wayne Clinical Site 111
Fort Wayne, Indiana, 46805
HighPoint Clinical Site 128
HighPoint, North Carolina, 27265
Indianapolis Clinical Site 121
Indianapolis, Indiana, 46202
Knoxville Clinical Site 134
Knoxville, Tennessee, 37934
Lebanon Clinical Site 115
Lebanon, New Hampshire, 03756
Northbrook Clinical Site 135
Northbrook, Illinois, 60062
Ormond Beach Clinical Site 129
Ormond Beach, Florida, 32174
Philadelphia Clinical Site 120
Philadelphia, Pennsylvania, 19104
Raleigh Clinical Site 103
Raleigh, North Carolina, 27607
Rochester Clinical Site 108
Rochester, New York, 14642
Round Rock Clinical Site 107
Round Rock, Texas, 78681
Sarasota Clinical Site 116
Sarasota, Florida, 34243
Sarasota Clinical Site 117
Sarasota, Florida, 34243
Seattle Clinical Site 118
Seattle, Washington, 98101
Tucson Clinical Site 133
Tucson, Arizona, 85741
Russia11 sites
Chelyabinsk Clinical Site 322
Chelyabinsk, 454136
Kaluga Clinical Site 328
Kaluga, 428007
Kazan Clinical Site 333
Kazan', 420103
Moscow Clinical Site 332
Moscow, 107150
Nizhniy Novgorod Clinical Site 321
Nizhny Novgorod, 603155
Novosibirsk Clinical Site 324
Novosibirsk, 630091
St. Petersburg Clinical Site 325
Saint Petersburg, 428007
St. Petersburg Clinical Site 327
Saint Petersburg, 428007
Samara Clinical Site 328
Samara, 443095
Ufa Clinical Site 326
Ufa, 450005
Yaroslavl Clinical Site 331
Yaroslavl, 150030
Germany9 sites
Berlin Clinical Site 223
Berlin, 13347
Essen Clinical Site 222
Essen, 45147
Giessen Clinical Site 221
Giessen, 35385
Leipzig Clinical Site 229
Leipzig, 04103
Mainz Clinical Site 231
Mainz, 55101
Marburg Clinical Site 228
Marburg, 35033
Munster Clinical Site 225
Münster, 48149
Tubingen Clinical Site 226
Tübingen, 72076
Ulm Clinical Site 230
Ulm, 89081
Japan9 sites
Kanto Region Clinical Site 404
Kanto
Kanto Region Clinical Site 405
Kanto
Kanto Region Clinical Site 406
Kanto
Kanto Region Clinical Site 409
Kanto
Kinki Region Clinical Site 401
Kinki
Kinki Region Clinical Site 407
Kinki
Kinki Region Clinical Site 408
Kinki
Tohoku Region Clinical Site 403
Tōhoku
Tohoku Region Clinical Site 410
Tōhoku
Poland8 sites
Bialystok Clinical Site 305
Bialystok, 15-402
Czeladz Clinical Site 303
Czeladź, 41-250
Gdansk Clinical Site 302
Gdansk, 80-803
Katowice Clinical Site 309
Katowice, 40-594
Krakow Clinical Site 307
Krakow, 31-530
Lodz Clinical Site 306
Lodz, 90-153
Plewiska Clinical Site 304
Plewiska, 62-064
Warszawa Clinical Site 308
Warsaw, 04-749
Spain6 sites
Barcelona Clinical Site 252
Barcelona, 08025
Barcelona Clinical Site 253
Barcelona, 08025
Bilbao Clinical Site 255
Bilbao, 48013
Girona Clinical Site 254
Girona, 17007
Hospitalet de Llobregat Clinical Site 251
L'Hospitalet de Llobregat, 08907
Sevilla Clinical Site 256
Seville, 41071
Ukraine6 sites
Dnipropetrovsk Clinical Site 341
Dnipropetrovsk, 49027
Donetsk Clinical Site 345
Donetsk, 83000-490
Kharkiv Clinical Site 346
Kharkiv, 61068
Kyiv Clinical Site 344
Kyiv, 03110
Lviv Clinical Site 343
Lviv, 79010
Vinnytsya Clinical Site 342
Vinnytsia, 21005
Canada5 sites
Vancouver Clinical Site 131
British Columbia, V6T 2B5
Gatineau Clinical Site 114
Gatineau, Quebec
Greenfield Park Clinical Site 109
Greenfield Park, Quebec, J4V2J2
Montreal Clinical Site 113
Québec, H1T 2M4
Montreal Clinical Site 102
Québec, H9X 3Z9
Czechia4 sites
Olomouc Clinical Site 212
Olomouc, 775 20
Ostrava Clinical Site 214
Ostrava, 702 00
Pardubice Clinical Site 211
Pardubice, 532 03
Praha 5 Clinical Site 213
Prague, 150 06
Belgium3 sites
Brugge Clinical Site 203
Bruges, 8000
La Louviere Clinical Site 201
La Louvière, 7100
Sijsele Clinical Site 202
Sijsele, 8340
Greece2 sites
Athens Clinical Site 243
Athens, 11529
Thessaloniki Clinical Site 245
Thessaloniki, 57010
About this study
Official title: A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- ONO-4641, ONO-4641 placebo
- Keywords
- Multiple Sclerosis, ONO-4641
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4641Drug
0.15 mg once per day for 26 weeks
ONO-4641Drug
0.1 mg once per day for 26 weeks
ONO-4641Drug
0.05 mg once per day for 26 weeks
ONO-4641 placeboDrug
Placebo once per day for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | Not described Receives: Drug: ONO-4641 |
| E2 | Experimental | Not described Receives: Drug: ONO-4641 |
| E3 | Experimental | Not described Receives: Drug: ONO-4641 |
| P | Placebo comparator | Not described Receives: Drug: ONO-4641 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
Measured: 26 weeks
Secondary outcomes (1)
Total volume of Gd-enhanced lesions
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081782
- Sponsor's protocol ID
- ONO-4641POU006
- Acronym
- DreaMS
- Status last verified
- Nov 2013
- First submitted
- 4 Mar 2010
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01081782
- Acronym / sponsor ID
- DreaMS / ONO-4641POU006
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, ONO-4641
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Drug: ONO-4641 |
| E2 | Experimental | Drug: ONO-4641 |
| E3 | Experimental | Drug: ONO-4641 |
| P | Placebo comparator | Drug: ONO-4641 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult male or female aged 18-55 years inclusive at screening
- Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-46410.15 mg once per day for 26 weeks | Drug | E1 |
| ONO-46410.1 mg once per day for 26 weeks | Drug | E2 |
| ONO-46410.05 mg once per day for 26 weeks | Drug | E3 |
| ONO-4641 placeboPlacebo once per day for 26 weeks | Drug | P |
Primary outcome
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
Time frame: 26 weeks
1 secondary outcome
Total volume of Gd-enhanced lesions
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
86 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4641 in people with Multiple Sclerosis, run by Ono Pharma USA Inc at 86 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Russia, Germany, Japan, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.