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

Nocturnal Hypokinesia Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03098368
• Other study ID #: JSringean
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 13, 2017
• Last updated: March 27, 2017
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: February 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypokinesia
• Nocturnal Hypokinesia

Intervention

Drug:
• Rotigotine

• Placebo
Placebo of rotigotine patch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal parameters from wearable sensors during nighttime	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.	up to 10 hours
Secondary	Nocturnal Akinesia Dystonia Cramp score (NADCs)	The nocturnal akinesia dystonia cramp score (NADCs) questionnaire was asked before and after participants got the interventions in both active and placebo groups.	Before and after maintenance dosage intervention within 1 month.
Secondary	PDSS-2	The Parkinson's disease sleep scale- 2 questionnaire was asked before and after participants got the interventions in both active and placebo groups.	Before and after maintenance dosage intervention within 1 month.