Staedt 1997.
Methods | Randomised active controlled crossover trial of levodopa versus pergolide Dropouts/withdrawals: Total N of 11, no premature discontinuations |
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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 |
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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 |
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Outcomes | Objective quality of sleep: Change in sleep parameters (TST) Safety: Number of dropouts due to adverse events, number of patients experiencing adverse events |
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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. |