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Randomized clinical trial of fipamezole for dyskinesia in Parkinson disease (FJORD study)
Neurology, 07/17/2012
Clinical Article
LeWitt PA et al. – The evidence of efficacy in the US subgroup suggested that fipamezole at 90 mg TID may be useful to treat levodopa–induced dyskinesias (LID) in Parkinson disease (PD) without exacerbating parkinsonism.
Methods- This was a double-blind, randomized, placebo-controlled, dose-escalating 28-day study in levodopa-treated patients with PD experiencing LID, conducted at 25 centers in the United States (115 subjects) and 7 centers in India (64 subjects).
- Dyskinesias were evaluated 3 times after subjects became “on” from levodopa.
- Outcome assessment was performed with analysis of variance, which evaluated fipamezole dose-effects in a hierarchical stepwise manner and the Jonckheere test for dose responsiveness.
- The total study population showed no statistically significant primary endpoint difference.
- However, because of inhomogeneity recognized between US and Indian study populations, a prespecified subgroup analysis of US subjects was conducted, showing fipamezole at 90 mg reduced LID (mean, 95% CI, LID rating improvement vs placebo -1.9 [0.0 to -3.8; p=0.047]).
- Dose responsiveness was demonstrated (p=0.014 for placebo, 30, 60, and 90 mg fipamezole).
- Fipamezole induced mild, transient blood pressure elevation and was associated with an acceptable profile of adverse effects.
