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

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03098368

Collaborator

Abbott (Industry)

Enrollment

Arms

19.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Hypokinesia	Drug: Rotigotine Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Rotigotine Other Names: Neupro patch
Placebo Comparator: 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.	Drug: Placebo Placebo of rotigotine patch Other Names: Control group

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Rotigotine

Other Names:

Neupro patch

Placebo Comparator: 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.

Drug: Placebo

Placebo of rotigotine patch

Other Names:

Control group

Outcome Measures

Primary Outcome Measures

Nocturnal parameters from wearable sensors during nighttime [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.

Secondary Outcome Measures

Nocturnal Akinesia Dystonia Cramp score (NADCs) [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.
PDSS-2 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chulalongkorn University
Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT03098368

Other Study ID Numbers:

JSringean

First Posted:

Mar 31, 2017

Last Update Posted:

Mar 31, 2017

Last Verified:

Feb 1, 2017

Keywords provided by Chulalongkorn University

Parkinson's disease

Rotigotine transdermal patch

Nocturnal hypokinesia

Additional relevant MeSH terms:

Hypokinesia

Rotigotine

Study Results

No Results Posted as of Mar 31, 2017