Related Experiment Videos
ESIMS--an ongoing clinical trial in secondary progressive multiple sclerosis
1European Charcot Foundation, Nijmegen, The Netherlands.
Multiple Sclerosis (Houndmills, Basingstoke, England)
|February 24, 2001
Summary
This study investigated intravenous immunoglobulin (IVIG) for secondary progressive multiple sclerosis (MS). Results are pending, but the trial design focuses on clinical and MRI outcomes over 27 months.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Multiple Sclerosis (MS) is a chronic neurological disease.
- Secondary progressive MS (SPMS) is a disabling form of the disease.
- Effective treatments for SPMS are limited.
Purpose of the Study:
- To evaluate the efficacy of intravenous immunoglobulin (IVIG) in patients with SPMS.
- To assess the impact of IVIG on clinical disability progression.
- To investigate the effects of IVIG on MRI-derived measures of MS pathology.
Main Methods:
- A double-blind, placebo-controlled, European-Canadian study design.
- 318 SPMS patients received monthly IVIG (1 g/kg) or placebo (albumin) for 27 months.
- Primary endpoint: treatment failure (EDSS/Nine Hole Peg Test). Secondary endpoints: MRI lesion load, Magnetization Transfer Imaging, brain atrophy.
Main Results:
- Patient recruitment completed in October 1998.
- Clinical trial completion scheduled for April 2001.
- Socio-economic data (health resource use, work ability) were collected.
Conclusions:
- The study provides a robust design for evaluating IVIG in SPMS.
- Findings will inform treatment strategies for progressive MS.
- The trial addresses both clinical and radiological outcomes.