drugset / Trial / NCT03098368

Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors

NCT03098368

Phase 4 Unknown 40 enrolled Chulalongkorn University Abbott · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies deposition in central and peripheral nervous system. The mains symptoms include both motor and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability, autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in the nighttime is called nocturnal hypokinesia which also make many serious consequences such as bedsore, falling or aspiration or death. In this study, the investigators aim to study the effects of rotigotine transdermal patch compare to placebo on mainly the aspect of nocturnal hypokinesia.

Timeline

Start
2016-09
Primary completion
2017-12
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rotigotine Unknown 16 mg Other

Indications