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A Study for Patients With Multiple Sclerosis

NCT ID: NCT00870155

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Secondary Progressive Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dirucotide

Group Type EXPERIMENTAL

dirucotide

Intervention Type DRUG

500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination

Interventions

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dirucotide

500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination

Intervention Type DRUG

Other Intervention Names

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MBP8298 LY2820671

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMS Technology Corp.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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

Eli Lilly and Company

Locations

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St. Michaels Hospital

Toronto, Ontario, Canada

Site Status

Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

West Tallinn Central Hospital

Tallinn, , Estonia

Site Status

Terveystalo Turku Kuvantaminen

Turku, , Finland

Site Status

Heinrich Heine Universitaets

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Vecmilgravis Hospital

Riga, , Latvia

Site Status

Maaslandziekenhuis

Sittard, , Netherlands

Site Status

Hospital Duran I Reynals

Barcelona, , Spain

Site Status

Karolinska Universitetssjukhus

Stockholm, , Sweden

Site Status

Walton Hospital

Liverpool, , United Kingdom

Site Status

Countries

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Canada Denmark Estonia Finland Germany Latvia Netherlands Spain Sweden United Kingdom

Other Identifiers

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I3E-BM-MSAC

Identifier Type: -

Identifier Source: secondary_id

2007-001480-30

Identifier Type: -

Identifier Source: secondary_id

MBP8298-SP-02

Identifier Type: -

Identifier Source: secondary_id

12789

Identifier Type: -

Identifier Source: org_study_id