- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098368
Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Patient (active) group
|
Other Names:
|
Placebo Comparator: Control (placebo) group
Placebo transdermal patch were titration with the same protocol as active group. Duration up to 12 weeks
|
Placebo of rotigotine patch
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nocturnal parameters from wearable sensors during nighttime
Time Frame: up to 10 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nocturnal Akinesia Dystonia Cramp score (NADCs)
Time Frame: Before and after maintenance dosage intervention within 1 month.
|
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.
|
PDSS-2
Time Frame: Before and after maintenance dosage intervention within 1 month.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSringean
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nocturnal Hypokinesia
-
Sleep Medicine Centre KempenhaegheTerminatedNocturnal Hypokinesia | Parkinsons's Disease | RotigotineNetherlands
-
Mansoura UniversityCompleted
-
Duramed ResearchCompletedNocturnal Vasomotor SymptomsUnited States
-
Mansoura UniversityRecruitingNocturnal Polyurea in Patients With BPHEgypt
-
The University of Hong KongThe Hong Kong Jockey Club Charities Trust; Caritas Medical Centre, Hong KongCompleted
-
IMAC Holdings, Inc.UnknownBradykinesiaUnited States
-
National Taiwan University HospitalUnknownHypokinetic DysathriaTaiwan
-
Ankara Education and Research HospitalCompletedMyocardial Ischemia | Cardiovascular Diseases | Early Repolarization Syndrome | Electrocardiogram: Electrical Alternans | Left Ventricular HypokinesiaTurkey
-
University GhentCompletedMonosymptomatic Nocturnal EnuresisBelgium
-
Shanghai Institute of HypertensionRecruitingNocturnal HypertensionChina
Clinical Trials on Rotigotine
-
UCB PharmaOtsuka Pharmaceutical Co., Ltd.Completed
-
UCB PharmaCompleted
-
UCB Biopharma SRLTerminatedRestless Legs SyndromeUnited States
-
I.R.C.C.S. Fondazione Santa LuciaCompletedAlzheimer DiseaseItaly
-
UCB BIOSCIENCES GmbHCompleted
-
I.R.C.C.S. Fondazione Santa LuciaAlzheimer's Drug Discovery FoundationActive, not recruitingMental Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Neurologic Manifestations | Neurobehavioral Manifestations | Neurocognitive Disorders | Neurodegenerative Diseases | TDP-43 Proteinopathies | Proteostasis Deficiencies | Dementia | Language Disorders | Communication... and other conditionsItaly
-
UCB BIOSCIENCES GmbHPharmaceutical Health Sciences; Bracket GlobalCompleted
-
Otsuka Pharmaceutical Co., Ltd.CompletedIdiopathic Restless Legs Syndrome
-
Otsuka Pharmaceutical Co., Ltd.Completed