A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A present there is no safe treatment for reducing rate at which disability worsens in people with secondary progressive multiple sclerosis. Recent research has suggested the possibility that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres in the brain and spinal cord. In this trial, the investigators will test whether one such drug, called lamotrigine, can prevent damage to nerve fibres and reduce the rate at which MS worsens. The period of treatment in the trial will run for 2 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College London Hospitals
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• Age 18 to 60

• Progression rather than clinical relapse is the major cause for increased disability over the preceding 2 years

• EDSS 4.0-6.5

Exclusion Criteria:

• Very rapid deterioration in EDSS, >2 points over 6 months

• Use of Mitoxantrone in the preceding year

• Use of sodium channel blockers or calcium channel blockers in the preceding 2 weeks

• Use of corticosteroids in preceding 2 months

• Use of neuroprotective agents or immunosuppressants in the preceding 6 months

• Evidence of significant hepatic or renal impairment either in clinical history or blood results.

• Prior untoward reactions to lamotrigine, or severe temperature dependent symptoms

• Contraindications to MRI