Clinical trial NCT00869726: A Study for Patients With Secondary Progressive Multiple Sclerosis
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Secondary Progressive Multiple Sclerosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: BioMS Technology Corp.
First posted: 2009-03-26
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
timeFrame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Secondary outcomes:
measure: degree of change in EDSS
timeFrame: baseline, 24mos
measure: Brain Atrophy by MRI
timeFrame: baseline, 12mos, 24mos
measure: Activity analysis of T2 and Gadolinium enhancing lesions
timeFrame: 12mos and 24mos
measure: Lesion burden
timeFrame: 12mos and 24mos
measure: Degree of change in MS Functional Composite Index (MSFC)
timeFrame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
measure: Relapse rates
timeFrame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
measure: Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
timeFrame: baseline, 6mos, 12mos, 18mos, 24mos
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
city: Kobenhavn
country: Denmark
facility: Copenhagen University Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Turku
country: Finland
facility: Terveystalo Turku Kuvantaminen
city: Duesseldorf
country: Germany
facility: Heinrich Heine Universitaets
city: Riga
country: Latvia
facility: Vecmilgravis Hospital
city: Sittard
country: Netherlands
facility: Maaslandziekenhuis
city: Barcelona
country: Spain
facility: Hospital Duran I Reynals
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhus
city: Liverpool
country: United Kingdom
facility: Walton Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: