A Study for Patients With Secondary Progressive Multiple Sclerosis - Full Text View

Sponsor:	Eli Lilly and Company
Collaborator:	BioMS Technology Corp.
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00869726

Purpose

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.

Condition	Intervention	Phase
Secondary Progressive Multiple Sclerosis	Drug: dirucotide Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

degree of change in EDSS [ Time Frame: baseline, 24mos ] [ Designated as safety issue: No ]
Brain Atrophy by MRI [ Time Frame: baseline, 12mos, 24mos ] [ Designated as safety issue: No ]
Activity analysis of T2 and Gadolinium enhancing lesions [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
Lesion burden [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
Degree of change in MS Functional Composite Index (MSFC) [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
Relapse rates [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [ Time Frame: baseline, 6mos, 12mos, 18mos, 24mos ] [ Designated as safety issue: No ]

Enrollment:	596
Study Start Date:	December 2004
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dirucotide	Drug: dirucotide 500mg, intravenous, dosed once every six months for 18 months Other Names: MBP8298 LY2820671
Placebo Comparator: Placebo	Drug: Placebo intravenous, once every six months for 18 months

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869726

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, Germany, 40225
Latvia
Vecmilgravis Hospital
Riga, Latvia, 1015
Netherlands
Maaslandziekenhuis
Sittard, Netherlands, 6131 BK
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 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:	NCT00869726 History of Changes
Other Study ID Numbers:	12788, I3E-BM-MSAB, MBP8298-01
Study First Received:	March 24, 2009
Last Updated:	May 27, 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
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012