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

Chulalongkorn University

Status and phase: Unknown; Phase 4

Conditions: Nocturnal Hypokinesia

Treatments: Drug: Placebo; Drug: Rotigotine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03098368

JSringean

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Patient (active) group

Active Comparator group

Description:

* 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.

Treatment:

Drug: Rotigotine

Control (placebo) group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo