An open-label follow-on study to assess the ongoing safety of MBP8298 in subjects with secondary progressive multiple sclerosis

ISRCTN	ISRCTN31894936
DOI	https://doi.org/10.1186/ISRCTN31894936
Protocol serial number	MBP8298-SP-02
Sponsor	BioMS Medical (Canada)
Funder	BioMS Medical (Canada)

Submission date: 22/03/2007
Registration date: 18/05/2007
Last edited: 13/11/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Roxanne Morton
Scientific

6030-88 Street
Edmonton
T6E 6G4
Canada

Study information

Primary study design	Interventional
Study design	Open-label extension study
Secondary study design	Other
Scientific title
Study objectives	Safety assessment.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	27/07/2009
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Key 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
Key exclusion criteria	1. Pregnancy or desire to become pregnant 2. Use of any concomitant disease modifying therapy for Multiple Sclerosis (MS)
Date of first enrolment	27/02/2007
Date of final enrolment	27/07/2009

Locations

Countries of recruitment

United Kingdom
Canada
Denmark
Estonia
Finland
Germany
Latvia
Netherlands
Spain
Sweden

Study participating centre

6030-88 Street

Edmonton
T6E 6G4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan