Condition category
Nervous System Diseases
Date applied
13/06/2005
Date assigned
20/09/2005
Last edited
01/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Freedman

ORCID ID

Contact details

501 Smyth Road
Ottawa
K1H 8L6
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MBP8298-01

Study information

Scientific title

Acronym

Study hypothesis

The major clinical hypothesis is that MBP8298 will significantly delay the progression of disability, as measured by the Expanded Disability Status Scale (EDSS), in subjects diagnosed with Secondary Progressive Multiple Sclerosis and who are human leukocyte antigen (HLA) DR2 and/or DR4 positive.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Secondary Progressive Multiple Sclerosis

Intervention

An intravenous administration of MBP peptide versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

MBP8298

Primary outcome measures

To compare the clinical efficacy of 500 mg MBP8298 given intravenously every 6 months for a period of 2 years, to placebo, in subjects diagnosed with SPMS who are positive for the HLA DR2 and/or DR4 haplotype. Clinical efficacy is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.

Secondary outcome measures

1. To assess safety of MBP8298 synthetic peptide in all subjects irrespective of genotype
2. To compare the clinical efficacy of 500 mg MBP8298 given intravenously every 6 months for a period of 2 years, to placebo, in subjects diagnosed with SPMS who are negative for the HLA DR2 and/or DR4 haplotype. Clinical efficacy is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.
3. To assess the effects of MBP8298 on MRI parameters:
3.1. Activity analysis (T2 lesions, Gadolinium-enhancing lesions)
3.2. Lesion burden (T2 burden of disease, chronic T1 black holes)
3.3. Atrophy (brain and cervical cord)
4. To confirm that treatment with MBP8298 induces immunological tolerance or shift in functional response profile to MBP peptide (82-98) and determine whether this is dependent on HLA subtype
5. To determine whether MBP8298 induces immunological tolerance or shift in functional response profile to other MBP epitopes and other myelin antigens (e.g., proteolipid protein [PLP], myelin oligodendrocyte glycoprotein [MOG]), indicating the stop of epitope spreading and whether this too is dependent on HLA subtype
6. To confirm the ratio of HLA DR2/4 positive to HLA DR2/4 negative subjects in the SPMS population
7. To determine whether MBP8298 induces an improvement in the quality of life of SPMS patients, as determined by the MSQoL-54 (SF-36 plus 18 MS-specific questions in Sweden and Norway)

Overall trial start date

06/12/2004

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female subjects, 18-65 years of age
2. Documented history of SPMS. SPMS is defined as an MS patient who has been diagnosed with MS for at least 3 years, and in the 3-year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS) in the absence of acute relapses. (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes will be acceptable). The subject must also have experienced at least one acute relapse as part of their diagnosis of Relapsing/Remitting Multiple Sclerosis (RRMS). Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial magnetic resonance imaging (MRI) findings consistent with the diagnosis of MS are also present.
3. Absence of relapse in the 3 months prior to baseline
4. EDSS of 3.5 – 6.5
5. Pyramidal or Cerebellar FSS ≥3
6. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
7. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

553

Participant exclusion criteria

1. Diagnosis of Primary Progressive MS
2. Subjects have previously received MBP8298
3. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
4. Steroid therapy within 30 days prior to first dose, or any other treatment known to be used for putative or experimental MS treatment
5. Therapy with ß-interferon, glatiramer acetate, mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g., intravenous immunoglobulin [IVIG]) or immunosuppressive drugs, including recombinant or non-recombinant cytokines or plasma exchange, within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or adrenocorticotropic hormone (ACTH) for relapse treatment.
6. Initiation of therapy with 4-aminopyridine (4-AP) or 3,4-diaminopyridine (3,4-DAP)
7. History of anaphylactic/anaphylactoid reactions to glatiramer acetate
8. Abnormal laboratory values at the Baseline Visit deemed by the Investigator to be clinically significant
9. Known allergy to Gadolinium-DTPA
10. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, anti-VLA4, anti-CD20
11. Treatment at any time with an altered peptide ligand
12. Any conditions that could interfere with the performance of study-specific procedures (e.g., MRI)
13. Previous randomization to this study
14. Known positivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
15. Participation in any other non-MS clinical trial within 30 days prior to performance of the first study-specific test (the screening/baseline visit), or any investigational therapy in the past 6 months
16. Females who are breastfeeding, pregnant (pregnancy test at screening), or not using a medically approved method of contraception regularly
17. Known or suspected current or past alcohol or drug abuse (within the last year)
18. 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
19. Any other condition that, in the Investigator’s opinion, makes the subject unsuitable for participation in the study

Recruitment start date

06/12/2004

Recruitment end date

01/05/2008

Locations

Countries of recruitment

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

Trial participating centre

501 Smyth Road
Ottawa
K1H 8L6
Canada

Sponsor information

Organisation

BioMS Technology Corp (Canada)

Sponsor details

6030 - 88 Street
Edmonton
T6E 6G4
Canada
+1 780 413 7152
tverco@biomsmedical.com

Sponsor type

Industry

Website

http://www.biomsmedical.com

Funders

Funder type

Industry

Funder name

BioMS Technology Corp (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21975206

Publication citations

  1. Results

    Freedman MS, Bar-Or A, Oger J, Traboulsee A, Patry D, Young C, Olsson T, Li D, Hartung HP, Krantz M, Ferenczi L, Verco T, , A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS., Neurology, 2011, 77, 16, 1551-1560, doi: 10.1212/WNL.0b013e318233b240.

Additional files

Editorial Notes