Clinical trial NCT03098368: Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nocturnal Hypokinesia
Keywords: Parkinson's disease
Rotigotine transdermal patch
Nocturnal hypokinesia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2017-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients: PD patients (age ≥ 18 years) who have history of nocturnal hypokinesia
* Patients not taking levodopa were eligible for study
* Patients who taking immediate- released levodopa,they had been on a stable dose for 28 days prior to baseline assessment and during the study
* Patients did not use control-released L-dopa at bedtime

Exclusion Criteria:

* History of narcolepsy, excessive daytime sleepiness, sudden onset of sleep
* History of hallucination, dementia and psychosis
* Evidence of ICDs
* Clinical relevant to cardiovascular disorders (including prolonged QTc ≥ 500 ms, recent MI)
* History of seizure or stroke in the past 1 year
* Patients had participated in other clinical trial in the past 28 days

Primary outcomes:
measure: Nocturnal parameters from wearable sensors during nighttime
timeFrame: up to 10 hours
Secondary outcomes:
measure: Nocturnal Akinesia Dystonia Cramp score (NADCs)
timeFrame: Before and after maintenance dosage intervention within 1 month.
measure: PDSS-2
timeFrame: Before and after maintenance dosage intervention within 1 month.
Other outcomes:
Locations:
Study officials:
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