Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease (APOMORPHEE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02940912|
Recruitment Status : Unknown
Verified August 2016 by Clinique Beau Soleil.
Recruitment status was: Recruiting
First Posted : October 21, 2016
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Apomorphine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: 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.
Other Name: Apokinon
Placebo Comparator: Physiologic serum
Physiological serum (from 0.1 ml to maximum 1 ml/ hour), delivered with a pump (subcutaneous administration), during 22 days.
Other Name: Physiologic Serum
- Change from baseline PDSS2 score (Parkinson's Disease Sleep Scale) at the end of the sequence [ Time Frame: 53 days ]This score is a score range, it's the difference between PDSS2 score at day18 and day 1 (for the first sequence) and difference between day 53 and day 36 (for the second sequence).
- Total sleep time period [ Time Frame: 53 days ]Variable will be measured from the polysomnography recordings
- Total sleep time (non-Rapid Eye Movements (REM) stages 1,2,3 plus REM sleep) [ Time Frame: 53 days ]Variables will be measured from the polysomnography recordings
- Length of the intra-sleep wakefulness [ Time Frame: 53 days ]
- Sleep efficiency (total sleep time based on the total sleep period) [ Time Frame: 53 days ]
- Duration of each sleep stage of the total sleep time [ Time Frame: 53 days ]
- Subjective sleepiness on the Epworth Sleepiness Scale [ Time Frame: 53 days ]
- Sleep latency (between light extinction and the first period of sleep) [ Time Frame: 53 days ]
- Arousal index [ Time Frame: 53 days ]
- Apnea / hypopnea Index [ Time Frame: 53 days ]
- Percentage of time spent with a saturation below 90% [ Time Frame: 53 days ]
- Periodic leg movement index [ Time Frame: 53 days ]
- Percentage of REM sleep time with tonic and phasic activity [ Time Frame: 53 days ]
- Objective sleepiness on Multiple Sleep Latency Test [ Time Frame: 53 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940912
|Contact: Lacombe Sandy||0467459397 ext +email@example.com|
|Chu Gabriel Montpied||Not yet recruiting|
|Clermont-Ferrand, France, 63001|
|Contact: Maria Livia FANTINI, MD, PhD +33473751666|
|Hôpital de la TIMONE||Not yet recruiting|
|Marseille, France, 13385|
|Contact: Isabelle LAMBERT, MD|
|Clinique Beau Soleil||Recruiting|
|Montpellier, France, 34070|
|Contact: Valérie COCHEN DE COCK|
|CHU de NANTES - HOPITAL NORD||Not yet recruiting|
|Nantes, France, 44093|
|Contact: Laurene LECLER-VISONNEAU, MD|
|CHU de NIMES||Not yet recruiting|
|Nîmes, France, 30029|
|Contact: Beatriz ABRIL, MD|
|Chu Ponchaillou||Not yet recruiting|
|Rennes, France, 35033|
|Contact: Marc VERIN, MD, PhD|
|Hôpital CIVIL||Not yet recruiting|
|Strasbourg, France, 67091|
|Contact: Isabelle RUPPERT, MD, PhD|
|Hôpital de HAUTEPIERRE||Not yet recruiting|
|Strasbourg, France, 67200|
|Contact: Mathieu ANHEIM, MD, PhD|
|Centre hospitalier JACQUES LACARIN||Not yet recruiting|
|Vichy, France, 03200|
|Contact: Nicolas VITELLO, MD|
|Principal Investigator:||Valérie COCHEN DE COCK, PI, MD, PhD||Clinique BEAU SOLEIL, 34070 Montpellier|
|Principal Investigator:||Emmanuel FLAMAND-ROZE, PI, MD, PhD||Hopital PITIE-SALPETRIERE, 75013 Paris|