An Open label Follow-On Study to Assess the Ongoing Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis.

Phase 2

Completed

Conditions: MS
Multiple Sclerosis
10012303

Registration Number: NL-OMON32699

Lead Sponsor: ICON Clinical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

1. Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study *A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis*,
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. In the Investigator*s opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.

Exclusion Criteria

1. Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
2. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
3. Any other condition that, in the Investigator*s opinion, makes the subject unsuitable for participation in the study.
4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse Events<br /><br>Blood pressure and heart rate<br /><br>12-Lead ECG*s<br /><br>Clinical Chemistry and Haematology<br /><br>Changes in physical examination results</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The EDSS is the most commonly accepted numerical measure of the clinical status<br /><br>of an MS subject. The EDSS is an ordinal variable ranging from 0-10 in<br /><br>increments of 0.5. The clinical efficacy of MBP8298 will be assessed by<br /><br>evaluating the time to progression as measured by EDSS in subjects receiving<br /><br>MBP8298 as an IV injection every 6 months.<br /><br><br /><br>Degree of change in EDSS, mean EDSS change, and change in area under the EDSS<br /><br>curve.<br /><br><br /><br>Relapse rates.<br /><br><br /><br>Assessment of efficacy as measured by the MSFC.<br /><br><br /><br>Differences in subject Quality of Life as measured by the MSQoL54/SF-36.<br /><br><br /><br>MRI parameters, all subjects will continue to have MRIs performed with and<br /><br>without gadolinium enhancement on an annual basis. MRIs will be brain only</p><br>