Status:
TERMINATED
A Study for Patients With Multiple Sclerosis
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
BioMS Technology Corp.
Conditions:
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjec...
Eligibility Criteria
Inclusion
- Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis",
- Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
- In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.
Exclusion
- Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
- Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
- Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
- Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT00870155
Start Date
February 1 2007
End Date
September 1 2009
Last Update
September 9 2010
Active Locations (10)
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1
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
2
Copenhagen University Hospital
Copenhagen, Denmark, 2100
3
West Tallinn Central Hospital
Tallinn, Estonia, 10617
4
Terveystalo Turku Kuvantaminen
Turku, Finland, 20101