Nocturnal HypokinesiaPhase 4NCT03098368
Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
A Phase 4 study testing Rotigotine in people with Nocturnal Hypokinesia, run by Chulalongkorn University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Hypokinesia
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Nocturnal Hypokinesia
- Being tested
- Rotigotine, Placebo
- Keywords
- Parkinson's disease, Rotigotine transdermal patch, Nocturnal hypokinesia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro patch
PlaceboDrug
Also called Control group
Placebo of rotigotine patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 hours
Secondary outcomes (2)
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.
Measured: Before and after maintenance dosage intervention within 1 month.
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.
Measured: Before and after maintenance dosage intervention within 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal HypokinesiaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098368
- Sponsor's protocol ID
- JSringean
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
- ClinicalTrials.gov ID
- NCT03098368
- Acronym / sponsor ID
- JSringean
- Conditions
- Nocturnal Hypokinesia
- Keywords
- Parkinson's disease, Rotigotine transdermal patch, Nocturnal hypokinesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient (active) group | Active comparator | Drug: Rotigotine* 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. |
| Control (placebo) group | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RotigotineAlso: Neupro patch | Drug | Patient (active) group |
| PlaceboAlso: Control groupPlacebo of rotigotine patch | Drug | Control (placebo) group |
Primary outcome
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.
2 secondary outcomes
Nocturnal Akinesia Dystonia Cramp score (NADCs)
Time frame: Before and after maintenance dosage intervention within 1 month.
PDSS-2
Time frame: Before and after maintenance dosage intervention within 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotigotine in people with Nocturnal Hypokinesia, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal parameters from wearable sensors during nighttime (time frame: up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.