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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT02940912 |
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Date of registration:
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14/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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January 31, 2017 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02940912 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Valérie COCHEN DE COCK, PI, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique BEAU SOLEIL, 34070 Montpellier |
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Name:
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Emmanuel FLAMAND-ROZE, PI, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital PITIE-SALPETRIERE, 75013 Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Apomorphine
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline PDSS2 score (Parkinson's Disease Sleep Scale) at the end of the sequence
[Time Frame: 53 days]
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Secondary Outcome(s)
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Subjective sleepiness on the Epworth Sleepiness Scale
[Time Frame: 53 days]
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Arousal index
[Time Frame: 53 days]
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Periodic leg movement index
[Time Frame: 53 days]
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Apnea / hypopnea Index
[Time Frame: 53 days]
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Percentage of REM sleep time with tonic and phasic activity
[Time Frame: 53 days]
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Total sleep time period
[Time Frame: 53 days]
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Sleep efficiency (total sleep time based on the total sleep period)
[Time Frame: 53 days]
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Sleep latency (between light extinction and the first period of sleep)
[Time Frame: 53 days]
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Duration of each sleep stage of the total sleep time
[Time Frame: 53 days]
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Percentage of time spent with a saturation below 90%
[Time Frame: 53 days]
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Length of the intra-sleep wakefulness
[Time Frame: 53 days]
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Objective sleepiness on Multiple Sleep Latency Test
[Time Frame: 53 days]
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Total sleep time (non-Rapid Eye Movements (REM) stages 1,2,3 plus REM sleep)
[Time Frame: 53 days]
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Secondary ID(s)
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2015-005793-37
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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