A Study for Patients With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869726
• Other study ID #: 12788
• Secondary ID: I3E-BM-MSABMBP82
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 24, 2009
• Last updated: May 27, 2010
• Start date: December 2004
• Est. completion date: May 2009

Study information

• Verified date: May 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesLatvia: State Agency of MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Neoplasm Metastasis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Drug:
• dirucotide
500mg, intravenous, dosed once every six months for 18 months
• Placebo
intravenous, once every six months for 18 months

Locations

Country	Name	City	State
Canada	St. Michaels Hospital	Toronto	Ontario
Denmark	Copenhagen University Hospital	Kobenhavn
Estonia	West Tallinn Central Hospital	Tallinn
Finland	Terveystalo Turku Kuvantaminen	Turku
Germany	Heinrich Heine Universitaets	Duesseldorf
Latvia	Vecmilgravis Hospital	Riga
Netherlands	Maaslandziekenhuis	Sittard
Spain	Hospital Duran I Reynals	Barcelona
Sweden	Karolinska Universitetssjukhus	Stockholm
United Kingdom	Walton Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	BioMS Technology Corp.

Countries where clinical trial is conducted

Canada,  Denmark,  Estonia,  Finland,  Germany,  Latvia,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).		baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos	No
Secondary	degree of change in EDSS		baseline, 24mos	No
Secondary	Brain Atrophy by MRI		baseline, 12mos, 24mos	No
Secondary	Activity analysis of T2 and Gadolinium enhancing lesions		12mos and 24mos	No
Secondary	Lesion burden		12mos and 24mos	No
Secondary	Degree of change in MS Functional Composite Index (MSFC)		baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos	No
Secondary	Relapse rates		baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos	No
Secondary	Quality of life as measured by Short Form 36 (SF-36) or MSQoL54		baseline, 6mos, 12mos, 18mos, 24mos	No