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

NCT00257855 | Completed Phase 2 DMC

• 1 other identifier: 2005-001949-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Progressive Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis; Neuroprotection; Axonal loss; Brain atrophy; MRI; Lamotrigine; Sodium Channel Blockers

Outcome Measures

Primary Outcomes (1)

• Change in central brain volume on MRI using the 'Loseff method'

Secondary Outcomes (9)

• Change in whole brain volume on MRI using Brain Boundary Shift Integral

• Number and volume of new T2 high intensity lesion volume on T2 weighted MRI

• Number and volume of new T1 low signal lesion volume on T1 weighted MRI

• Ratio of new T1 to new T2 lesions on MRI

• Change in magnetisation transfer ratio in normal MRI normal appearing white matter and normal appearing grey matter.

Interventions

Lamotrigine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

National Hospital for Neurology and Neurosurgery

London, WC1 3BG, United Kingdom

Location

Related Publications (1)

• Kapoor R, Furby J, Hayton T, Smith KJ, Altmann DR, Brenner R, Chataway J, Hughes RA, Miller DH. Lamotrigine for neuroprotection in secondary progressive multiple sclerosis: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):681-8. doi: 10.1016/S1474-4422(10)70131-9. Epub 2010 Jun 8.

  PMID: 20621711 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Raju Kapoor, MD PhD

  National Hospital for Neurology and Neurosurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 23, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 8, 2010

Record last verified: 2009-02

Locations

GB (1)