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
Secondary identifying numbers MBP8298-SP-02
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

Study designOpen-label extension study
Primary study designInterventional
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesSafety 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) studiedSecondary Progressive Multiple Sclerosis
InterventionAll 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 typeOther
Primary outcome measureAn 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 measures1. 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 study start date27/02/2007
Completion date27/07/2009
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsUp to 600
Key inclusion criteria1. 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 investigator’s opinion
Key exclusion criteria1. Pregnancy or desire to become pregnant
2. Use of any concomitant disease modifying therapy for Multiple Sclerosis (MS)
Date of first enrolment27/02/2007
Date of final enrolment27/07/2009

Locations

Countries of recruitment

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

Study participating centre

6030-88 Street
Edmonton
T6E 6G4
Canada

Sponsor information

BioMS Medical (Canada)
Industry

6030-88 Street
Edmonton
T6E 6G4
Canada

Website http://biomsmedical.com
ROR logo "ROR" https://ror.org/03fvjvp95

Funders

Funder type

Industry

BioMS Medical (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan