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

Lilly

Status and phase

Completed

Phase 3

Phase 2

Conditions

Secondary Progressive Multiple Sclerosis

Treatments

Drug: dirucotide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00869726

MBP8298-01 (Other Identifier)

12788

I3E-BM-MSAB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

596 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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