Walker 1996.
Methods | Randomised controlled crossover trial of levodopa versus placebo Dropouts/withdrawals: PP (5) with premature discontinuations of 3 patients prior to start of trial |
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Participants | Included/analysed: 8/5 Demographics: 1 male, age 68.2 years Diagnosis: RLS according to Diagnostic Classification Steering Committee 1990 Setting: 1 centre in Canada No baseline values given |
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Interventions | Intervention: fixed single dose of 100 mg/25 mg levodopa/carbidopa for 1 week Control: fixed single dose of placebo capsules for 1 week Washout for 1 week between treatment periods |
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Outcomes | Objective quality of sleep: Change in sleep parameters (TST), PLMSI (using PSG) Safety: number of dropouts due to adverse events, number of patients with adverse events |
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funding source | The study was supported by the Kidney Foundation of Canada, Manitoba Branch, The Medical Research Council of Canada and Baxter Healthcare corporation. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Insufficient information. |
Allocation concealment? | Unclear risk | Insufficient information. |
Blinding? All outcomes | Low risk | Blinded scorers for PSG rating. |
Incomplete outcome data addressed? All outcomes | Low risk | No incomplete outcome data. |
Free of selective reporting? | Low risk | All results reported as prespecified with results of additional sleep parameters partly reported. |
Free of other bias? | Low risk | Low indication of bias. |