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A Study for Patients With Secondary Progressive Multiple Sclerosis (MAESTRO-01)

Primary Purpose

Secondary Progressive Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dirucotide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented history of SPMS
  • Absence of relapse in the 3mos prior to baseline
  • EDSS of 3.5 - 6.5
  • Pyramidal or Cerebellar FSS greater than or equal to 3
  • A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive.
  • Informed consent
  • Subject reliability and compliance

Exclusion Criteria:

  • Diagnosis of Primary Progressive MS
  • Subjects have previously received MBP8298
  • Recent history of malignancy, with the exclusion on basal cell carcinoma.
  • Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment
  • Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
  • Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period.
  • History of anaphylactic/anaphlactoid reactions to glatiramer acetate
  • Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant
  • Known allergy to Gadolinium-DTPA
  • Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment
  • Treatment at any time wtih an altered peptide ligand
  • Any conditions that could interfere with the performance of study specific procedures e.g.MRI
  • Previous randomization to this study
  • Known positivity for HIV, Hepatitis B, or Hepatitis C
  • Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos.
  • Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly
  • Known or suspected current or past alcohol or drug abuse (within the last year)
  • 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

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 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dirucotide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).

Secondary Outcome Measures

degree of change in 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

First Posted
March 24, 2009
Last Updated
May 27, 2010
Sponsor
Eli Lilly and Company
Collaborators
BioMS Technology Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00869726
Brief Title
A Study for Patients With Secondary Progressive Multiple Sclerosis
Acronym
MAESTRO-01
Official Title
A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
BioMS Technology Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dirucotide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dirucotide
Other Intervention Name(s)
MBP8298, LY2820671
Intervention Description
500mg, intravenous, dosed once every six months for 18 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous, once every six months for 18 months
Primary Outcome Measure Information:
Title
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
Time Frame
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Secondary Outcome Measure Information:
Title
degree of change in EDSS
Time Frame
baseline, 24mos
Title
Brain Atrophy by MRI
Time Frame
baseline, 12mos, 24mos
Title
Activity analysis of T2 and Gadolinium enhancing lesions
Time Frame
12mos and 24mos
Title
Lesion burden
Time Frame
12mos and 24mos
Title
Degree of change in MS Functional Composite Index (MSFC)
Time Frame
baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Title
Relapse rates
Time Frame
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Title
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time Frame
baseline, 6mos, 12mos, 18mos, 24mos

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: Documented history of SPMS Absence of relapse in the 3mos prior to baseline EDSS of 3.5 - 6.5 Pyramidal or Cerebellar FSS greater than or equal to 3 A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive. Informed consent Subject reliability and compliance Exclusion Criteria: Diagnosis of Primary Progressive MS Subjects have previously received MBP8298 Recent history of malignancy, with the exclusion on basal cell carcinoma. Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment. Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period. History of anaphylactic/anaphlactoid reactions to glatiramer acetate Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant Known allergy to Gadolinium-DTPA Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment Treatment at any time wtih an altered peptide ligand Any conditions that could interfere with the performance of study specific procedures e.g.MRI Previous randomization to this study Known positivity for HIV, Hepatitis B, or Hepatitis C Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly Known or suspected current or past alcohol or drug abuse (within the last year) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 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
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
6131 BK
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

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A Study for Patients With Secondary Progressive Multiple Sclerosis

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