Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MBP8298-SP-02
Study information
Scientific title
Acronym
Study hypothesis
Safety assessment.
Ethics approval
The study was approved by Health Canada on 15/11/2006. Individual site approvals in Canada are ongoing, with one site currently approved and enrolling patients. Regulatory submission for the UK is pending as of 22/03/2007. All other country submissions including those for Sweden, Finland, Netherlands, Denmark, Spain, Latvia, Germany, and Estonia will occur between October 2007 and October 2008.
Study design
Open-label extension study
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Secondary Progressive Multiple Sclerosis
Intervention
All participants will receive 500 mg of MBP8298 intravenously once every 6 months until the termination of the study.
As of 12/08/2009 this record has been updated to include the stopped status; this trial was terminated easrly by the sponsor. The initial anticipated end date of this trial was 27/02/2011.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
An independent pharmacovigilance group will provide safety oversight through an ongoing and regular review of serious adverse events and aggregate laboratory alert values from all subjects to identify any potential new safety data trends. The group will confer at least quarterly with the medical monitor and will notify the sponsor within 24 hours of the observance of any potential new safety findings.
The following evaluations will be made for safety assessment each time the participant comes for an injection of study drug:
1. Evaluation of adverse events
2. Laboratory results
3. Electrocardiogram (ECG) results
4. Vital signs
5. Physical examinations
Secondary outcome measures
1. Expanded Disability Status Scale (EDSS) change, measured once every 6 months (prior to each dose)
2. Quality of life, measured once every 6 months (prior to each dose) by Multiple Sclerosis Quality of Life-54 (MSQoL-54). In countries where this tool has not been translated into the local language, the Short Form-36 is used.
3. Relapse rates (each confirmed relapse will be recorded)
Brain magnetic resonance imaging (MRI) scans will be carried out on an annual basis to assess the effects of MBP8298:
4. Activity analysis (T2 lesions, gadolinium enhancing lesions)
5. Lesion burden (T2 burden of disease, chronic T1 black holes)
6. Atrophy (brain)
Overall trial start date
27/02/2007
Overall trial end date
27/07/2009
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
1. Completion of treatment and all required evaluations of MBP8298-SP-01(ISRCTN record of this trial at http://www.controlled-trials.com/ISRCTN98373474)
2. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
3. Subjects must be reliable, compliant, and agree to cooperate with all trial evaluations in the investigators opinion
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Up to 600
Participant exclusion criteria
1. Pregnancy or desire to become pregnant
2. Use of any concomitant disease modifying therapy for Multiple Sclerosis (MS)
Recruitment start date
27/02/2007
Recruitment end date
27/07/2009
Locations
Countries of recruitment
Canada, Denmark, Estonia, Finland, Germany, Latvia, Netherlands, Spain, Sweden, United Kingdom
Trial participating centre
6030-88 Street
Edmonton
T6E 6G4
Canada
Sponsor information
Organisation
BioMS Medical (Canada)
Sponsor details
6030-88 Street
Edmonton
T6E 6G4
Canada
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
BioMS Medical (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
Basic results (scientific)
Publication list