Clinical trial NCT00870155: A Study for Patients With Multiple Sclerosis
Official title: An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Secondary Progressive Multiple Sclerosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: BioMS Technology Corp.
First posted: 2009-03-27
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.


Eligibility criteria: Inclusion Criteria:

1. 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",
2. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
3. In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.

Exclusion Criteria:

1. 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.
2. 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.
3. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.

Primary outcomes:
measure: To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
timeFrame: every 6 mos
Secondary outcomes:
measure: Degree of change in Kurtzke Expended Disability Status (EDSS)
timeFrame: every 6mos
measure: Brain atrophy by MRI
timeFrame: every 6mos
measure: Activity analysis of T2 and Gadolinium enhancing lesions
timeFrame: every 6mos
measure: Lesion burden
timeFrame: every 6mos
measure: Degree of change in MS Functional Composite Index (MSFC)
timeFrame: every 6mos
measure: Relapse rates
timeFrame: every 6mos
measure: Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
timeFrame: every 6mos
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
city: Kobenhavn
country: Denmark
facility: Copenhagen University Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Turku
country: Finland
facility: Terveystalo Turku Kuvantaminen
city: Duesseldorf
country: Germany
facility: Heinrich Heine Universitaets
state: North Rhine Westphalia
city: Riga
country: Latvia
facility: Vecmilgravis Hospital
city: Sittard
country: Netherlands
facility: Maaslandziekenhuis
city: Barcelona
country: Spain
facility: Hospital Duran I Reynals
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhus
city: Liverpool
country: United Kingdom
facility: Walton Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: