Skip to main content
. 2005 Jul 20;2005(3):CD004898. doi: 10.1002/14651858.CD004898.pub2

Norway‐Denmark 1999.

Methods G: unknown 
 C: central allocation 
 Patients/doctors/assessors blind 
 Not intention‐to‐treat
Participants Norway and Denmark 
 163 randomised 
 77 to selegiline; 86 to placebo 
 Incl: untreated idiopathic PD or levodopa < 6 months, H&Y I ‐ III 
 Excl: age <35 or >75, dementia, psychosis, unstable diseases 
 Baseline mean UPDRS: selegiline 37; placebo 35
Interventions Treatment: selegiline 10 mg daily 
 Control: placebo 
 Both groups also received levodopa 
 Duration of treatment: up to 5 years
Outcomes Deaths 
 UPDRS 
 Mean levodopa dose 
 Motor fluctuations
Dyskinesia 
 Withdrawals due to side‐effects 
 Total withdrawals
Notes Mean FU: selegiline 2.9 yrs; placebo 3.1 yrs 
 1 month washout
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomisation was done centrally by the study monitor in each country"
Comment: Probably random
Allocation concealment (selection bias) Low risk Quote: "randomisation was done centrally by the study monitor in each country"
Comment: Central allocation.
Blinding (performance bias and detection bias) 
 Doctors, All outcomes Unclear risk Quote: “Double‐blind”
Quote: "Sealed envelopes containing the treatment code were added to the study material. The code was broken by the data analyst after the analyses were done.” Unclear if envelopes were opaque and placebo identical.
Incomplete outcome data (attrition bias) 
 Mortality Low risk Rx: 77 randomised, 73 analysed
C: 86 randomised, 81 analysed
9 excluded (three protocol violations, six not deemed to have Parkinson’s disease after one year FU). Data not given by randomised group.
Incomplete outcome data (attrition bias) 
 Parkinsonian impairment & disability Unclear risk Rx: 77 randomised, 62 analysed (reason for withdrawals unclear)
C: 86 randomised, 73 analysed (reasons for withdrawlas unclear)
Incomplete outcome data (attrition bias) 
 Participants requiring levodopa Low risk Outcome not assessed
Incomplete outcome data (attrition bias) 
 Motor fluctuations & dyskinesias High risk Rx: 77 randomised, 65 analysed (reasons for withdrawal not given)
C; 86 randomised, 72 analysed (reasons for withdrawal not given)
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Unclear risk Different mean durations of FU: slightly longer in control arm (2.9 vs 3.1 yrs).
Quote: “supported by Orion Pharma”