A Study for Patients With Secondary Progressive Multiple Sclerosis

Phase 2

Completed

• Conditions: Secondary Progressive Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: dirucotide

• Registration Number: NCT00869726
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-26
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-05
• Disposition First Submitted: 2010-05-27
• Disposition First Submitted QC: 2010-05-27
• Last Update Submitted: 2010-05-27
• Disposition First Posted: 2010-06-02
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dirucotide	dirucotide	-

Primary Outcome Measures

Name	Time	Method
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).	baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos

Secondary Outcome Measures

Name	Time	Method
Brain Atrophy by MRI	baseline, 12mos, 24mos
degree of change in EDSS	baseline, 24mos
Activity analysis of T2 and Gadolinium enhancing lesions	12mos and 24mos
Relapse rates	baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54	baseline, 6mos, 12mos, 18mos, 24mos
Lesion burden	12mos and 24mos
Degree of change in MS Functional Composite Index (MSFC)	baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos

Trial Locations

Locations (10)

Vecmilgravis Hospital; 🇱🇻 Riga, Latvia

West Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia

Terveystalo Turku Kuvantaminen; 🇫🇮 Turku, Finland

Karolinska Universitetssjukhus; 🇸🇪 Stockholm, Sweden

Copenhagen University Hospital; 🇩🇰 Kobenhavn, Denmark

St. Michaels Hospital; 🇨🇦 Toronto, Ontario, Canada

Heinrich Heine Universitaets; 🇩🇪 Duesseldorf, Germany

Maaslandziekenhuis; 🇳🇱 Sittard, Netherlands

Hospital Duran I Reynals; 🇪🇸 Barcelona, Spain

Walton Hospital; 🇬🇧 Liverpool, United Kingdom