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 | |
| 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 | |
| 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 | |
| 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 | |
| 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. |