Back to resultsRotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
Primary Purpose
Nocturnal Hypokinesia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rotigotine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Hypokinesia focused on measuring Parkinson's disease, Rotigotine transdermal patch, Nocturnal hypokinesia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patient (active) group
Control (placebo) group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03098368
First Posted
February 13, 2017
Last Updated
March 27, 2017
Sponsor
Chulalongkorn University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT03098368
Brief Title
Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
Collaborators
Abbott
4. Oversight
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Hypokinesia
Keywords
Parkinson's disease, Rotigotine transdermal patch, Nocturnal hypokinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The active drugs and placebo were labeled from the company and the study nurse would give the drug to participants who were randomized.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient (active) group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control (placebo) group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro patch
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control group
Intervention Description
Placebo of rotigotine patch
Primary Outcome Measure Information:
Title
Nocturnal parameters from wearable sensors during nighttime
Description
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.
Time Frame
up to 10 hours
Secondary Outcome Measure Information:
Title
Nocturnal Akinesia Dystonia Cramp score (NADCs)
Description
The nocturnal akinesia dystonia cramp score (NADCs) questionnaire was asked before and after participants got the interventions in both active and placebo groups.
Time Frame
Before and after maintenance dosage intervention within 1 month.
Title
PDSS-2
Description
The Parkinson's disease sleep scale- 2 questionnaire was asked before and after participants got the interventions in both active and placebo groups.
Time Frame
Before and after maintenance dosage intervention within 1 month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
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