Clinical trial

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

Name

2015-005793-37

Description

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.

Trial arms

Trial start

2017-01-31

Estimated PCD

2021-01-31

Trial end

2021-04-12

Status

Completed

Phase

Early phase I

Treatment

Apomorphine

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

Arms:

Apomorphine (5 mg/ml)

Other names:

Apokinon

Placebo

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

Arms:

Physiologic serum

Other names:

Physiologic Serum

Size

Primary endpoint

Change from baseline PDSS2 score (Parkinson's Disease Sleep Scale) at the end of the sequence

53 days

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

Updated at

2024-04-25

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug