Peltola 2009.
| Methods | Randomised, double‐blind, placebo‐controlled trial 2 treatment arms: 1 PCB and 1 LEV XR Randomisation concealment: interactive voice response system. Random list generation: randomised 1:1 using interactive voice response system Blinding: identical tablets and packages, all study personnel and participants were described as being blinded to treatment assignment Baseline: 8 weeks. Treatment period = 12 weeks (no up‐titration took place) |
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| Participants | All adults. Multicentre (7 centres) including centres in Finland, India, Mexico, Russia, South Africa, and Ukraine
Total randomised: 158 adults
79 adults to PCB 79 adults to LEV XR 1000 mg 59% male in PCB and 66% male in LEV XR Age range 12 to 70 years Other AEDs 1 to 3 ≥ 8 focal seizures during 8‐week baseline within which ≥ 2 focal seizures per 4 weeks Diagnosis of uncontrolled focal epilepsy made ≥ 6 months before screening Mean duration of epilepsy (± SD) (years): LEV XR 13.11 ± 10.87 (range 0.8 to 42.6), PCB 16.43 ± 11.93 (range 0.7 to 53.5) Mean baseline seizure frequency per week (mean ± SD): LEV XR 40.7 ± 66.0; PCB 30.6 ± 52.5 |
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| Interventions | LEV XR 1000 mg PCB |
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| Outcomes | ≥ 50% reduction in seizure frequency Treatment withdrawal Adverse effects |
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| Notes | 5 participants excluded from 50% responder analysis: 4 in LEV XR 1000 mg, 1 in PCB 2 patients randomised to LEV XR did not receive any medication; therefore, they were excluded from the safety population, leaving 77 patients on LEV XR and 79 on PCB in the safety analysis data‐set Baseline level for determining reduction in seizure frequency was derived from 74 patients in LEV XR group and 78 in PCB A few participants had other seizure types in addition to partial‐onset seizures "Study personnel" taken to mean investigators |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A ‐ Adequate |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | A ‐ Adequate |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | A ‐ Adequate |
| Selective reporting (reporting bias) | Low risk | A ‐ Adequate |