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. 2011 Feb 15;2011(2):CD005504. doi: 10.1002/14651858.CD005504.pub2

Staedt 1997.

Methods Randomised active controlled crossover trial of levodopa versus pergolide
Dropouts/withdrawals: Total N of 11, no premature discontinuations
Participants Included/analysed: 11
Demographics: 6 male, age 57.6 years
Diagnosis: patients with a history of restlessness and paraesthesias at night and/or day
Setting: 1 centre in Germany
Baseline: PLMS‐disturbed time of sleep 164 ± 80.4 min
Interventions Intervention 1: flexible uptitration of single dose levodopa/benserazide from 200 mg/50 mg to 400 mg/100 mg in 16 days
Intervention 2: flexible uptitration of single dose pergolide from 0.125 mg to 0.25 mg in 16 days
Washout of 24 hours between treatment periods
Outcomes Objective quality of sleep: Change in sleep parameters (TST)
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? Unclear risk Insufficient information.
Allocation concealment? Unclear risk Insufficient information.
Blinding? 
 All outcomes Unclear risk Insufficient information, not mentioned if research staff were blinded.
Incomplete outcome data addressed? 
 All outcomes Low risk No incomplete outcome data.
Free of selective reporting? Low risk All results reported as prespecified, additional sleep data reported.
Free of other bias? Low risk Low indication of bias.