Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With P… (NCT02940912) | Clinical Trial Compass
CompletedPhase 4
Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease
France45 participantsStarted 2017-01-31
Plain-language summary
The purpose of the study is to demonstrate that continuous apomorphine treatment during the night compared with placebo improves sleep quality in insomniac patient with Parkinson's disease.
Who can participate
Age range
35 Years – 90 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:
* Idiopathic Parkinson's disease ( Hughes AJ et al. 2001)
* Patients with motor fluctuations
* Chronic Insomnia disorder criteria according to the criteria of DMS- V ( American Psychiatric Association, 2013) and insomnia severity index \> 15
* Able to use independently the device required for treatment by apomorphine
* Collection of written informed consent (legal obligation for any project under the public health law , bioethics laws and / or CNIL) .
* Affiliate to social security or beneficiary of such a regime
Exclusion Criteria:
* Atypical Parkinsonian Syndromes
* Parkinson's disease with dementia (Montreal Cognitive Assessment (MoCA) \<25/30 (NASREDDINE and al., 2012))
* Parkinson's disease with hallucinations
* Parkinson's disease with impulse Control disorder (ICD)
* Parkinson's disease already treated with APOMORPHINE pump or justifying the use of the pump continuously day and night
* Another obvious severe disease explaining insomnia
* Exclusion for monitoring difficulties (mutation, insufficient motivation, priority associated pathology in care)
* Patient unwilling to accept a pump
* Patient not accepting polysomnography and multiple sleep latency test
* Patient with health problems or a skin disease precluding continuous subcutaneous infusion
* Female parturient or nursing
* Cardiac dysrhythmia precluding treatment with domperidone or apomorphine (increased QTc ≥ 440 ms in men, QTc ≥ 450 ms in women)
* Treatments forbid…
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
Change from baseline PDSS2 score (Parkinson's Disease Sleep Scale) at the end of the sequence