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

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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
Sponsor:
Information provided by (Responsible Party):
Clinique Beau Soleil

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Apomorphine Drug: Placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: Apomorphine
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.
Drug: Placebo
Other Name: Physiologic Serum




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Total sleep time period [ Time Frame: 53 days ]
    Variable will be measured from the polysomnography recordings

  2. 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

  3. Length of the intra-sleep wakefulness [ Time Frame: 53 days ]
  4. Sleep efficiency (total sleep time based on the total sleep period) [ Time Frame: 53 days ]
  5. Duration of each sleep stage of the total sleep time [ Time Frame: 53 days ]
  6. Subjective sleepiness on the Epworth Sleepiness Scale [ Time Frame: 53 days ]
  7. Sleep latency (between light extinction and the first period of sleep) [ Time Frame: 53 days ]
  8. Arousal index [ Time Frame: 53 days ]
  9. Apnea / hypopnea Index [ Time Frame: 53 days ]
  10. Percentage of time spent with a saturation below 90% [ Time Frame: 53 days ]
  11. Periodic leg movement index [ Time Frame: 53 days ]
  12. Percentage of REM sleep time with tonic and phasic activity [ Time Frame: 53 days ]
  13. Objective sleepiness on Multiple Sleep Latency Test [ Time Frame: 53 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lacombe Sandy 0467459397 ext +33 s.lacombe@languedoc-mutualite.fr

Locations
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France
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         
Sponsors and Collaborators
Clinique Beau Soleil
Investigators
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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
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Responsible Party: Clinique Beau Soleil
ClinicalTrials.gov Identifier: NCT02940912    
Other Study ID Numbers: 2015-005793-37
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: August 2016
Keywords provided by Clinique Beau Soleil:
Parkinson disease
Insomnia
Sleep disorders
Polysomnography
Apomorphine
Multiple sleep latency test
Parkinson Disease Sleep Scale 2 (PDSS-2)
Additional relevant MeSH terms:
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Parkinson Disease
Sleep Wake Disorders
Parasomnias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Mental Disorders
Apomorphine
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action