Back to resultsA Study for Patients With Multiple Sclerosis (MAESTRO-02)
Primary Purpose
Secondary Progressive Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dirucotide
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- St. Michaels Hospital
- Copenhagen University Hospital
- West Tallinn Central Hospital
- Terveystalo Turku Kuvantaminen
- Heinrich Heine Universitaets
- Vecmilgravis Hospital
- Maaslandziekenhuis
- Hospital Duran I Reynals
- Karolinska Universitetssjukhus
- Walton Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dirucotide
Arm Description
Outcomes
Primary Outcome Measures
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
Secondary Outcome Measures
Degree of change in Kurtzke Expended Disability Status (EDSS)
Brain atrophy by MRI
Activity analysis of T2 and Gadolinium enhancing lesions
Lesion burden
Degree of change in MS Functional Composite Index (MSFC)
Relapse rates
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Full Information
NCT ID
NCT00870155
First Posted
March 26, 2009
Last Updated
September 7, 2010
Sponsor
Eli Lilly and Company
Collaborators
BioMS Technology Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00870155
Brief Title
A Study for Patients With Multiple Sclerosis
Acronym
MAESTRO-02
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
Negative efficacy results of the MAESTRO-01 trial
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
BioMS Technology Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progressive Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
546 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dirucotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dirucotide
Other Intervention Name(s)
MBP8298, LY2820671
Intervention Description
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
Primary Outcome Measure Information:
Title
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
Time Frame
every 6 mos
Secondary Outcome Measure Information:
Title
Degree of change in Kurtzke Expended Disability Status (EDSS)
Time Frame
every 6mos
Title
Brain atrophy by MRI
Time Frame
every 6mos
Title
Activity analysis of T2 and Gadolinium enhancing lesions
Time Frame
every 6mos
Title
Lesion burden
Time Frame
every 6mos
Title
Degree of change in MS Functional Composite Index (MSFC)
Time Frame
every 6mos
Title
Relapse rates
Time Frame
every 6mos
Title
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time Frame
every 6mos
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
St. Michaels Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Copenhagen University Hospital
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Terveystalo Turku Kuvantaminen
City
Turku
ZIP/Postal Code
20101
Country
Finland
Facility Name
Heinrich Heine Universitaets
City
Duesseldorf
State/Province
North Rhine Westphalia
ZIP/Postal Code
40225
Country
Germany
Facility Name
Vecmilgravis Hospital
City
Riga
ZIP/Postal Code
1015
Country
Latvia
Facility Name
Maaslandziekenhuis
City
Sittard
ZIP/Postal Code
6131BK
Country
Netherlands
Facility Name
Hospital Duran I Reynals
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Karolinska Universitetssjukhus
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Walton Hospital
City
Liverpool
ZIP/Postal Code
L97LJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study for Patients With Multiple Sclerosis
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