Trenkwalder 1995.

Methods	Randomised controlled crossover trial of levodopa versus placebo Dropouts/withdrawals: PP of 28, 4 premature discontinuations (2 before drug intake)
Participants	Included/analysed: 32/28 Demographics: 18 male, age 52.0 years Diagnosis: primary and secondary RLS according to descriptive criteria, PLMS‐AI > 5, sleep onset latency > 25 and/or sleep efficiency < 85% Setting: 1 centre in Germany Baseline: severity on RLS rating scale 7.9 (0 to 10 points = severe)
Interventions	Intervention: flexible uptitration of single dose levodopa/benserazide from 100 mg/25 mg to 200 mg/50 mg in 2 weeks, maintenance for 2 weeks Control: single dose placebo capsules for 4 weeks No washout between treatment periods
Outcomes	Change of symptoms: CGI‐I, VAS on severity of RLS symptoms during the night Objective quality of sleep: TST, PLMSI (using PSG) Self rated quality of sleep: VAS on quality of sleep Quality of Life: VAS on life satisfaction Safety: Number of dropouts due to adverse events, number of patients experiencing adverse events
funding source	No funding stated.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Randomisation was done by the sponsor with a computer based system.
Allocation concealment?	Low risk	Patient randomisation numbers were allocated sequentially in the order of recruitment of patients. The allocated number was then the patient code.
Blinding? All outcomes	Unclear risk	Unblinding was done after the complete database had been transferred to the sponsor.
Incomplete outcome data addressed? All outcomes	Low risk	No incomplete outcome data.
Free of selective reporting?	Low risk	All results reported as prespecified with additional questionnaire data.
Free of other bias?	Low risk	Low indication of bias.