A Study for Patients With Multiple Sclerosis

Phase 2

Terminated

• Conditions: Secondary Progressive Multiple Sclerosis
• Interventions: Drug: dirucotide

• Registration Number: NCT00870155
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-09
• Disposition First Submitted: 2010-09-07
• Disposition First Submitted QC: 2010-09-07
• Last Update Submitted: 2010-09-07
• Disposition First Posted: 2010-09-09
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 546

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dirucotide	dirucotide	-

Primary Outcome Measures

Name	Time	Method
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes	every 6 mos

Secondary Outcome Measures

Name	Time	Method
Degree of change in Kurtzke Expended Disability Status (EDSS)	every 6mos
Brain atrophy by MRI	every 6mos
Activity analysis of T2 and Gadolinium enhancing lesions	every 6mos
Lesion burden	every 6mos
Degree of change in MS Functional Composite Index (MSFC)	every 6mos
Relapse rates	every 6mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54	every 6mos

Trial Locations

Locations (10)

St. Michaels Hospital; 🇨🇦 Toronto, Ontario, Canada

Copenhagen University Hospital; 🇩🇰 Kobenhavn, Denmark

West Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia

Terveystalo Turku Kuvantaminen; 🇫🇮 Turku, Finland

Heinrich Heine Universitaets; 🇩🇪 Duesseldorf, North Rhine Westphalia, Germany

Vecmilgravis Hospital; 🇱🇻 Riga, Latvia

Maaslandziekenhuis; 🇳🇱 Sittard, Netherlands

Hospital Duran I Reynals; 🇪🇸 Barcelona, Spain

Karolinska Universitetssjukhus; 🇸🇪 Stockholm, Sweden

Walton Hospital; 🇬🇧 Liverpool, United Kingdom