Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease

• Status: Active, not recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Beau Soleil
• Treatments: Apomorphine

Criteria

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 forbidden in association with apomorphine such as:

• antiemetic neuroleptics

• Tetrabenazine

• Excessive alcohol consumption

• Contraindications for apomorphine:

• Hypersensitivity to apomorphine or one of the excipients

• Respiratory Depression

• Hepatic impairment

• Intellectual Disability

• Dementia