A Study for Patients With Multiple Sclerosis

Secondary Progressive Multiple Sclerosis Clinical Trial

— MAESTRO-02  

Official title:

An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00870155
• Other study ID #: 12789
• Secondary ID: I3E-BM-MSAC2007-
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 26, 2009
• Last updated: September 7, 2010
• Start date: February 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesLatvia: State Agency of MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 546
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Drug:
• dirucotide
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination

Locations

Country	Name	City	State
Canada	St. Michaels Hospital	Toronto	Ontario
Denmark	Copenhagen University Hospital	Kobenhavn
Estonia	West Tallinn Central Hospital	Tallinn
Finland	Terveystalo Turku Kuvantaminen	Turku
Germany	Heinrich Heine Universitaets	Duesseldorf	North Rhine Westphalia
Latvia	Vecmilgravis Hospital	Riga
Netherlands	Maaslandziekenhuis	Sittard
Spain	Hospital Duran I Reynals	Barcelona
Sweden	Karolinska Universitetssjukhus	Stockholm
United Kingdom	Walton Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	BioMS Technology Corp.

Countries where clinical trial is conducted

Canada,  Denmark,  Estonia,  Finland,  Germany,  Latvia,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Degree of change in Kurtzke Expended Disability Status (EDSS)		every 6mos	No
Secondary	Brain atrophy by MRI		every 6mos	No
Secondary	Activity analysis of T2 and Gadolinium enhancing lesions		every 6mos	No
Secondary	Lesion burden		every 6mos	No
Secondary	Degree of change in MS Functional Composite Index (MSFC)		every 6mos	No
Secondary	Relapse rates		every 6mos	No
Secondary	Quality of life as measured by Short Form 36 (SF-36) or MSQoL54		every 6mos	No