Abstract
BackgroundFreezing of gait (FOG) is one of the most disabling symptoms in Parkinsonism. Open-label studies have suggested that intravenous (IV) amantadine is effective against FOG resistant to dopaminergic therapy in Parkinson's disease (PD). We evaluated the efficacy of IV amantadine on FOG resistant to dopaminergic therapy.Methodology/Principal FindingsThis was a randomized, double-blind, placebo-controlled, cross-over study on IV amantadine. The placebo (normal saline) and amantadine (400 mg/day) were injected for 2 days with a 52-hour washout period. The instruments for the outcome measures were the Freezing of Gait Questionnaire (FOGQ), Unified Parkinson's disease rating Scale (UPDRS), and the duration of the 4×10 m walking test. The placebo arm was compared to the amantadine arm. Ten patients were enrolled but two patients withdrew, one from each arm. The FOGQ and UPDRS scores and the duration of the 4×10 m walking test improved in both arms compared to the baseline (P<0.05 in all). However, there were no differences in these values between the amantadine arm and placebo arm (P = 0.368, P = 0.583, P = 0.206, respectively). Follow-up measures 2weeks after discharge in an open-label study showed the beneficial effects of an amantadine tablet on FOG (FOGQ, P = 0.018; UPDRS, P = 0.012 respectively).Conclusions/SignificanceThis double blind, placebo-controlled study did not show the efficacy of IV amantadine on FOG when compared with the placebo. This study provides Class II evidence due to small sample size for the lack of benefit of IV amantadine on FOG resistant to dopaminergic therapyTrial RegistrationClinicaltrials.gov NCT01313819
Highlights
Freezing of gait (FOG) is one of the most disabling symptoms in Parkinsonism [1]
One patient withdrew from each arm of the 1st admission for the following reasons: one patient in the amantadine arm was withdrawn due to a protocol violation because one patient took amantadine tablets secretly; one patient in the placebo arm was withdrawn due to delirium and hypertension, which continued for 3 hours on the 1st night of the 1st admission and fully recovered without any further complications
Compared to the baseline values, the mean Freezing of Gait Questionnaire (FOGQ) and Unified Parkinson’s disease rating Scale (UPDRS) III scores and the last UPDRS score and FOGQ score were significantly improved in the amantadine arm and the placebo arm
Summary
Freezing of gait (FOG) is one of the most disabling symptoms in Parkinsonism [1]. Nearly one-third of Parkinson’s disease (PD) patients experience some type of freezing episode [2]. Amantadine has been used for the treatment of PD since the late sixties [9,10], and the rapid effect of intravenously applied amantadine on PD motor signs has been acknowledged [11]. It has received attention for the treatment of levodopainduced dyskinesia [12]. Our preliminary study with intravenous (IV) amantadine showed that it might be effective in dopaminergic resistant FOG mainly in PD [16]. Open-label studies have suggested that intravenous (IV) amantadine is effective against FOG resistant to dopaminergic therapy in Parkinson’s disease (PD). We evaluated the efficacy of IV amantadine on FOG resistant to dopaminergic therapy
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