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

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ClinicalTrials.gov Identifier: NCT03098368
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Chulalongkorn University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

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 Name: 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 Name: Control group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03098368     History of Changes
Other Study ID Numbers: JSringean
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: February 2017
Keywords provided by Chulalongkorn University:
Parkinson's disease
Rotigotine transdermal patch
Nocturnal hypokinesia
Additional relevant MeSH terms:
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Hypokinesia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs