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

NCT03098368 | Unknown Phase 4

• 1 other identifier: JSringean
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nocturnal Hypokinesia

Keywords

Parkinson's disease; Rotigotine transdermal patch; Nocturnal hypokinesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nocturnal Akinesia Dystonia Cramp score (NADCs)

  Before and after maintenance dosage intervention within 1 month.

• PDSS-2

  Before and after maintenance dosage intervention within 1 month.

Study Arms (2)

Patient (active) group

ACTIVE COMPARATOR

* 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.

Drug: Rotigotine

Control (placebo) group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Rotigotine DRUG

Also known as: Neupro patch

Patient (active) group

Placebo DRUG

Placebo of rotigotine patch

Also known as: Control group

Control (placebo) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Abbott: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine; Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The active drugs and placebo were labeled from the company and the study nurse would give the drug to participants who were randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 31, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: March 31, 2017

Record last verified: 2017-02