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 range35 Years – 90 Years
SexALL
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…
What they're measuring
1
Change from baseline PDSS2 score (Parkinson's Disease Sleep Scale) at the end of the sequence