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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatments for Insomnia in Patients With Parkinson's Disease

NCT01489982

Parkinson's Disease Insomnia

COMPLETED EARLY_PHASE1

An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia

NCT03338764

Transient Insomnia

WITHDRAWN PHASE3

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone

NCT00324896

Parkinson's Disease Insomnia

COMPLETED PHASE3

Donepezil Treatment for Sleep Apnea Patients

NCT00912457

Obstructive Sleep Apnea

UNKNOWN PHASE4

Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity

NCT02464046

Insomnia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sleep disorders are very common in Parkinson's disease (PD). They are present in almost all patients. They have an important impact on quality of life. To improve the comfort of patients, neurologists typically offer either dispersible form of levodopa, prolonged release dopaminergic agonists treatments or deep brain stimulation surgery. Unfortunately these treatments are too short-acting for the dispersible form of levodopa or not always sufficient for the oral or transdermal dopamine agonist or are very heavy to implement as surgery.

Some sleep disorders such as restless legs syndrome and periodic leg movements, and obstructive sleep apnoea syndrome, seem to be more frequent in PD patients than in general population and could be improved by a continuous dopaminergic treatment the night.

Finally, daytime sleepiness is a major problem in PD patients. Although it seems most often linked to dopaminergic treatments given during the day, it could also be, in some patients the result of a very bad night's sleep, leading to a rebound of sleep during the day.

The main objective is to demonstrate that compared with placebo, nocturnal continuous apomorphine treatment improves sleep quality assessed by the patient on the PDSS-2 scale in fluctuating parkinsonian patients with complaints of insomnia.

The secondary objectives are to measure the effectiveness of nocturnal continuous apomorphine on sleep quality : total sleep time, sleep efficiency, arousal index, ventilatory events and legs movements indexes, to measure the relative proportion of sleep stages (N1, N2, N3, Rapid Eye Movement ou REM sleep), position changes during sleep index and the percentage of time spent in the supine position, percentage of time with SpO2 \<90%), sleepiness (Epworth and Multiple Sleep Latency Test) and their consequences on quality of life (EuroQol 5), depressive symptoms (Beck II), anxiety (STAI), overall cognition (MOCA), pain and engine condition after waking up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apomorphine (5 mg/ml)

Active phase is apomorphine (from 0.5 mg (0.1 ml) to maximum 5 mg (1 ml)/hour of apomorphine), delivered with a pump (subcutaneous administration), during 22 days.

Group Type ACTIVE_COMPARATOR

Apomorphine

Intervention Type DRUG

cross-over with start with Apokinon in the 1st phase- in the 2nd phase of continuous treatment with Physiologic Serum.

Physiologic serum

Physiological serum (from 0.1 ml to maximum 1 ml/ hour), delivered with a pump (subcutaneous administration), during 22 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

cross-over with start with.Physiologic Serum in the 1st phase- in the 2nd phase of continuous treatment with Apokinon.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apomorphine

cross-over with start with Apokinon in the 1st phase- in the 2nd phase of continuous treatment with Physiologic Serum.

Intervention Type DRUG

Placebo

cross-over with start with.Physiologic Serum in the 1st phase- in the 2nd phase of continuous treatment with Apokinon.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Apokinon Physiologic Serum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No