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

This study has been terminated.
(Negative efficacy results of the MAESTRO-01 trial)
Sponsor:
Collaborator:
BioMS Technology Corp.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00870155
First received: March 26, 2009
Last updated: September 7, 2010
Last verified: September 2010
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Degree of change in Kurtzke Expended Disability Status (EDSS) [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Brain atrophy by MRI [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Activity analysis of T2 and Gadolinium enhancing lesions [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Lesion burden [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Degree of change in MS Functional Composite Index (MSFC) [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Relapse rates [ Time Frame: every 6mos ] [ Designated as safety issue: No ]
  • Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [ Time Frame: every 6mos ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 26, 2009
Last Updated: September 7, 2010
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 20, 2014