Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (NCT01519882) | Clinical Trial Compass
TerminatedPhase 4
Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
Stopped: Due to major recruitment issues, a decision was made to terminate this trial
United Kingdom1 participantsStarted 2012-03
Plain-language summary
This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
* Hoehn and Yahr stage score of 2 to 4
* Subject has sleep-maintenance insomnia
Exclusion Criteria:
* Significant skin disease that would make transdermal drug use inappropriate
* Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone
* Atypical Parkinsonian syndromes
* Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)