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

NCT ID: NCT03098368

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Nocturnal Hypokinesia

Keywords

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Parkinson's disease Rotigotine transdermal patch Nocturnal hypokinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The active drugs and placebo were labeled from the company and the study nurse would give the drug to participants who were randomized.

Study Groups

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Patient (active) group

* Rotigotine titration up to 16 mg/24 hr
* Starting dose 2 mg/24 hr up titrate 2 mg weekly to optimal/maximum dose
* Duration up to 12 weeks
* The treatment was titrated until optimal dosage

* (that which patient/ caregiver felt that nocturnal hypokinesia and/or early morning akinesia was adequately controlled)
* (or patient can not tolerated the side effects such as dyskinesia)
* All previous dopaminergic medications were not allowed to adjusted during the study period.

Group Type ACTIVE_COMPARATOR

Rotigotine

Intervention Type DRUG

Control (placebo) group

Placebo transdermal patch were titration with the same protocol as active group.

Duration up to 12 weeks

* The treatment (placebo patch) was titrated until optimal dosage

* (that which patient/ caregiver felt that nocturnal hypokinesia and/or early morning akinesia was adequately controlled)
* (or patient can not tolerated the side effects such as dyskinesia)
* All previous dopaminergic medications were not allowed to adjusted during the study period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of rotigotine patch

Interventions

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Rotigotine

Intervention Type DRUG

Placebo

Placebo of rotigotine patch

Intervention Type DRUG

Other Intervention Names

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Neupro patch Control group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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JSringean

Identifier Type: -

Identifier Source: org_study_id