Nocturnal Hypokinesia Clinical Trial
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.
The investigators recruited PD patients who had history of nocturnal hypokinesia and randomized by running number (blind) into 2 groups including active and placebo group. Baseline demographic, disease characteristics, nocturnal questionnaires and wearable nocturnal sensors data were collected before drug titration. In active group, participants received the rotigotine transdermal patch titration from 2 mg/day to maximum dosage which participants had no side effect or 16 mg/ day every week. In placebo group, participants would get the placebo patch titration as the active group. After participants got maintenance dosage, participants would get the physical examination, nocturnal questionnaires and wearable nocturnal sensors as before study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01554306 -
Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease
|
N/A |