Condition category
Nervous System Diseases
Date applied
22/03/2007
Date assigned
18/05/2007
Last edited
13/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Roxanne Morton

ORCID ID

Contact details

6030-88 Street
Edmonton
T6E 6G4
Canada

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 measures

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

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 investigatorÂ’s 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

http://biomsmedical.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes