We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study for Patients With Multiple Sclerosis (MAESTRO-02)

This study has been terminated.
(Negative efficacy results of the MAESTRO-01 trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870155
First Posted: March 27, 2009
Last Update Posted: September 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BioMS Technology Corp.
Information provided by:
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Secondary Progressive Multiple Sclerosis Drug: dirucotide Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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 [ Time Frame: every 6 mos ]

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

Estimated Enrollment: 546
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dirucotide Drug: dirucotide
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
Other Names:
  • MBP8298
  • LY2820671

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870155


Locations
Canada, Ontario
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Denmark
Copenhagen University Hospital
Kobenhavn, Denmark, 2100
Estonia
West Tallinn Central Hospital
Tallinn, Estonia, 10617
Finland
Terveystalo Turku Kuvantaminen
Turku, Finland, 20101
Germany
Heinrich Heine Universitaets
Duesseldorf, North Rhine Westphalia, Germany, 40225
Latvia
Vecmilgravis Hospital
Riga, Latvia, 1015
Netherlands
Maaslandziekenhuis
Sittard, Netherlands, 6131BK
Spain
Hospital Duran I Reynals
Barcelona, Spain, 08907
Sweden
Karolinska Universitetssjukhus
Stockholm, Sweden, 14186
United Kingdom
Walton Hospital
Liverpool, United Kingdom, L97LJ
Sponsors and Collaborators
Eli Lilly and Company
BioMS Technology Corp.
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00870155     History of Changes
Other Study ID Numbers: 12789
I3E-BM-MSAC
2007-001480-30
MBP8298-SP-02
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: September 9, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms