Werhahn 2015.
| Methods | Randomised, double‐blind, parallel‐group trial conducted in 47 centres across Germany, Austria and Switzerland. 3 treatment arms: LTG, CBZ and LEV |
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| Participants | Adults > 60 years with newly diagnosed partial seizures, with a history of at least 2 seizures and at least 1 seizure in the previous 6 months. Participants must not have taken AEDs for more than 4 weeks Number randomised: LTG = 118, CBZ = 121, LEV = 122 215 male participants (60%) 100% of participants with partial epilepsy Not stated how many participants had received previous AED treatment Mean age(range): 71.5 (60‐95) years |
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| Interventions | Monotherapy with LEV, LTG or CBZ for 58 weeks 6‐week escalation phase leading to CBZ = 400 mg/d. LEV+ 1000 mg/d, LTG = 100 mg/d Range of follow‐up: 0‐54 months |
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| Outcomes | Retention rate at week 58 Time to discontinuation from randomisation Seizure‐freedom rates at week 30 and week 58 Time to first seizure from randomisation Time to first drug‐related adverse event Adverse events (by severity) |
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| Notes | IPD provided by trial author for time to treatment withdrawal, time to first seizure, time to six‐month and time to 12‐month remission | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A randomisation list for each centre (random permuted blocks) was prepared by the Interdisciplinary Centre for Clinical Trials (IZKS), Mainz, Germany |
| Allocation concealment (selection bias) | Low risk | The pharmacy of the University Hospital Mainz encapsulated the trial drugs and labelled the blinded medication including the randomisation number. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and trial investigator blinded by the use of matching capsules |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Trial investigator blinded, not stated if other outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2) |
| Selective reporting (reporting bias) | Low risk | Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2) |
| Other bias | Low risk | None identified |
1. Abbreviations: ADL: activities of daily living; AED: antiepileptic drug; BMI: body mass index; CBCL: child behavior checklist; CBZ: carbamazepine; EEG: electroencephalography; GBP: gabapentin; IPD: Iindividual participant data; ITT: intention to treat; LEV: levetiracetam; LTG: lamotrigine; OXC: oxcarbazepine; PHB: phenobarbitone; PHT: phenytoin; PSB: polysomnography; RCT: randomised controlled trial; REM: rapid eye movement; TPM: topiramate; VPS: sodium valproate; WISC: Wechsler Intelligence Scale for Children; ZNS: zonisamide
2. Attrition bias and reporting bias are reduced in trials for which IPD were provided, as attrition rates and unpublished outcome data were requested