Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
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|ClinicalTrials.gov Identifier: NCT03098368|
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was: Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Nocturnal Hypokinesia||Drug: Rotigotine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Active group is the group of PD patients who received rotigotine transdermal patch titration from 2 mg/day to maximum effect dose which participants had no side effect or reach 16 mg/day every week.
Placebo group is the group of PD patients who received the placebo patch titration every week the same protocol as the active group.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The active drugs and placebo were labeled from the company and the study nurse would give the drug to participants who were randomized.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Active Comparator: Patient (active) group
Other Name: Neupro patch
Placebo Comparator: Control (placebo) group
Placebo transdermal patch were titration with the same protocol as active group.
Duration up to 12 weeks
Placebo of rotigotine patch
Other Name: Control group
- Nocturnal parameters from wearable sensors during nighttime [ Time Frame: up to 10 hours ]The wearable sensors are the tri-axis accelerometer and gyrometer which will be attached at waist and wrist of patients up to 10 hours. The raw data from wearable sensors will be analyzed by MATLAB program. The results from MATLAB include the number of turning in bed.
- Nocturnal Akinesia Dystonia Cramp score (NADCs) [ Time Frame: Before and after maintenance dosage intervention within 1 month. ]The nocturnal akinesia dystonia cramp score (NADCs) questionnaire was asked before and after participants got the interventions in both active and placebo groups.
- PDSS-2 [ Time Frame: Before and after maintenance dosage intervention within 1 month. ]The Parkinson's disease sleep scale- 2 questionnaire was asked before and after participants got the interventions in both active and placebo groups.