Kapoor 2010.
| Study characteristics | ||
| Methods | Randomized placebo controlled trial Treating physicians, evaluating physicians, and participants were blinded Ex during trial: 11 on lamotrigine and 5 on placebo Losses to FU: 9 in the lamotrigine group and 3 in the placebo group | |
| Participants | Country: UK 120 participants Age: mean 51.9±7.1 years in Rx, mean 50.1±6.7 years in control Sex: 27.5% men People with secondary progressive multiple sclerosis aged 18‐55 years were eligible if they had an Expanded Disability Status Scale (EDSS) score of 4 to 6.5 and if their disability had increased in the preceding 2 years because of steady disease progression rather than relapse. Comparability: similar | |
| Interventions | Rx: lamotrigine (target dose 400 mg/day). Control: placebo Duration: 2 years | |
| Outcomes | Primary outcome: the rate of change of partial (central) cerebral volume over 24 months. Secondary imaging outcome measurements were whole brain volume, grey matter volume, white matter volume, mean cross sectional cervical spinal cord area, and T1 and T2 lesion volumes. Secondary clinical outcome measurements were the EDSS; the Multiple Sclerosis Functional Composite and its three components (25‐foot timed walk, 9‐hole peg test, and paced auditory serial addition test); and the Multiple Sclerosis Impact Scale. Adverse events. |
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| Notes | Participants were excluded if they were eligible for disease‐modifying treatments under the 2001 recommendations of the Association of British Neurologists, if drugs that block sodium or calcium channels had been used in the past 2 weeks, if corticosteroids had been used in the past 2 months, or if immunomodulatory drugs had been used in the previous 6 months (1 year for mitoxantrone). Exclusion criteria were pregnancy, major systemic disease, or disabling temperature‐dependent multiple sclerosis symptoms. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly assigned (1:1) to lamotrigine or placebo via a website by minimisation. |
| Allocation concealment (selection bias) | Low risk | Participants were given a randomisation number, which was matched to a confidential treatment number by the study pharmacist. The study pharmacist assigned participants either to lamotrigine or to placebo (of identical appearance). |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Treating physicians and participants were masked to treatment allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluating physicians were masked. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Twelve participants were lost to imaging follow‐up. 14.75% (9/61) in the lamotrigine group and 5.08% (3/59) in the placebo group. |
| Selective reporting (reporting bias) | Low risk | No obvious selective reporting was found. |
| Other bias | Low risk | None known. |
C: concealment of allocation Ex: exclusion FU: follow up Rx: treatment