| Methods |
Randomised double‐blind cross‐over study with two treatmement periods of 2 weeks each separated by a 1 week wash‐out interval. Random number tables were used, numbers 1 and 2 were assigned in blocks of four. The assignment was concealed using sequentially numbered opaque envelopes.
Results presented as combined data from both active treatment arms and both placebo arms.
Per protocol analysis.
Location: One centre in Austria.
Duration: 5 weeks. |
| Participants |
11 patients with 1 withdrawal.
4 patients were male, 7 female.
Mean age 63.5 years old (SD 8.2 years).
Mean disease duration 16.2 years (SD 6.2 years)
Mean dyskinesia duration 10.1 years (SD 5.1 years).
Mean Hoehn and Yahr stage 'On': 2.8 (SD1.2), 'Off': 3.8 (SD 0.9).
Mean levodopa dose 777 mg/day (range 450‐1300 mg/day).
Inclusion criteria: Advanced Parkinson's disease complicated by motor fluctuations and dyskinesias. Exclusion criteria: Dementia, renal hepatic or cardiac failure. |
| Interventions |
Amantadine was titrated to 100mg three times per day over three days with daily 100mg increments. Remaining antiparkinsonian medication unchanged during trial.
In addition oral levodopa challenges were performed before the first and last day of each treatment period. Antiparkinsonian medication was withheld overnight (12 hours) and the following morning patients were challenged with 100/25 or 200/50 mg of levodopa depending on their regularly scheduled levodopa morning dose. |
| Outcomes |
Primary: Marconi dyskinesia rating scale
Secondary: Part IV UPDRS and ADL Part II UPDRS in 'Off' state. Parkinsonian symptoms in 'On' and 'Off' states scored using UPDRS part III |
| Notes |
Cross‐over trial ‐ data presented as combined results of all treatment arms and all placebo arms. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
