An open-label follow-on study to assess the ongoing safety of MBP8298 in subjects with secondary progressive multiple sclerosis
Completed
- Conditions
- Secondary Progressive Multiple SclerosisNervous System DiseasesMultiple Sclerosis
- Registration Number
- ISRCTN31894936
- Lead Sponsor
- BioMS Medical (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
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 investigator?s opinion
Exclusion Criteria
1. Pregnancy or desire to become pregnant
2. Use of any concomitant disease modifying therapy for Multiple Sclerosis (MS)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>The following evaluations will be made for safety assessment each time the participant comes for an injection of study drug: <br>1. Evaluation of adverse events <br>2. Laboratory results <br>3. Electrocardiogram (ECG) results <br>4. Vital signs <br>5. Physical examinations
- Secondary Outcome Measures
Name Time Method 1. Expanded Disability Status Scale (EDSS) change, measured once every 6 months (prior to each dose)<br>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.<br>3. Relapse rates (each confirmed relapse will be recorded)<br><br>Brain magnetic resonance imaging (MRI) scans will be carried out on an annual basis to assess the effects of MBP8298: <br>4. Activity analysis (T2 lesions, gadolinium enhancing lesions) <br>5. Lesion burden (T2 burden of disease, chronic T1 black holes) <br>6. Atrophy (brain)