We included studies meeting the following criteria: (1) randomized controlled trials; (2) written in English; (3) included patients with PD and motor fluctuations or wearing-off who received levodopa; (4) included as outcomes at least one of the following endpoints: change in daily off-time, discontinuation due to all causes, discontinuation due to AEs, and incidences of AEs, dyskinesia, hallucination, and OH; (5) compared placebo with anti-PD drug(s) or among anti-PD drugs (selected anti-PD drugs: pramipexole, pramipexole ER, ropinirole, ropinirole ER, ropinirole transdermal patch, rotigotine transdermal patch, rasagiline, safinamide, selegiline, entacapone, opicapone, and istradefylline); (6) included study arms at approved dosage of selected anti-PD drugs in Japan, the USA, EU, or UK.
In addition, we excluded studies meeting the following criteria: (1) narrative reviews, systematic reviews, meta-analyses, meeting summaries; (2) no original data (previously reported data only).
In addition to the publications from the literature search, six eligible reports from CTD for drug application in Japan (available from the website of the Pharmaceuticals and Medical Devices Agency, which is a Japanese regulatory agency) of the targeted drugs were also included.
In addition, we excluded studies meeting the following criteria: (1) narrative reviews, systematic reviews, meta-analyses, meeting summaries; (2) no original data (previously reported data only).
In addition to the publications from the literature search, six eligible reports from CTD for drug application in Japan (available from the website of the Pharmaceuticals and Medical Devices Agency, which is a Japanese regulatory agency) of the targeted drugs were also included.
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