NCT02940912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4 parkinson-disease

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_4 parkinson-disease

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

April 25, 2024

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

October 14, 2016

Last Update Submit

April 24, 2024

Conditions

Parkinson Disease

Keywords

Parkinson diseaseInsomniaSleep disordersPolysomnographyApomorphineMultiple sleep latency testParkinson Disease Sleep Scale 2 (PDSS-2)

Outcome Measures

Primary Outcomes (1)

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

    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).

    53 days

Secondary Outcomes (13)

  • Total sleep time period

    53 days

  • Total sleep time (non-Rapid Eye Movements (REM) stages 1,2,3 plus REM sleep)

    53 days

  • Length of the intra-sleep wakefulness

    53 days

  • Sleep efficiency (total sleep time based on the total sleep period)

    53 days

  • Duration of each sleep stage of the total sleep time

    53 days

  • +8 more secondary outcomes

Study Arms (2)

Apomorphine (5 mg/ml)

ACTIVE COMPARATOR

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

Physiologic serum

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ApomorphineDRUG

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

Also known as: Apokinon
Apomorphine (5 mg/ml)
PlaceboDRUG

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

Also known as: Physiologic Serum
Physiologic serum

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chu Gabriel Montpied

Clermont-Ferrand, 63001, France

Location

Hôpital de la TIMONE

Marseille, 13385, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHU de NANTES - HOPITAL NORD

Nantes, 44093, France

Location

CHU de NIMES

Nîmes, 30029, France

Location

Chu Ponchaillou

Rennes, 35033, France

Location

Hôpital CIVIL

Strasbourg, 67091, France

Location

Hôpital de HAUTEPIERRE

Strasbourg, 67200, France

Location

Centre hospitalier JACQUES LACARIN

Vichy, 03200, France

Location

Related Publications (1)

  • De Cock VC, Dodet P, Leu-Semenescu S, Aerts C, Castelnovo G, Abril B, Drapier S, Olivet H, Corbille AG, Leclair-Visonneau L, Sallansonnet-Froment M, Lebouteux M, Anheim M, Ruppert E, Vitello N, Eusebio A, Lambert I, Marques A, Fantini ML, Devos D, Monaca C, Benard-Serre N, Lacombe S, Vidailhet M, Arnulf I, Doulazmi M, Roze E. Safety and efficacy of subcutaneous night-time only apomorphine infusion to treat insomnia in patients with Parkinson's disease (APOMORPHEE): a multicentre, randomised, controlled, double-blind crossover study. Lancet Neurol. 2022 May;21(5):428-437. doi: 10.1016/S1474-4422(22)00085-0.

    PMID: 35429481DERIVED

MeSH Terms

Conditions

Parkinson DiseaseSleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AporphinesBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 21, 2016

Study Start

January 31, 2017

Primary Completion

January 31, 2021

Study Completion

April 12, 2021

Last Updated

April 25, 2024

Record last verified: 2021-02

Locations

FR(9)