Title :

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.

Author(s) :

De Cock, Valérie Cohen [Auteur]
Université de Montpellier [UM]
Dodet, P. [Auteur]
Leu-Semenescu, S. [Auteur]
Aerts, C. [Auteur]
Castelnovo, G. [Auteur]
Abril, B. [Auteur]
Drapier, S. [Auteur]
Olivet, H. [Auteur]
Corbillé, A. G. [Auteur]
Leclair-Visonneau, L. [Auteur]
Sallansonnet-Froment, M. [Auteur]
Lebouteux, M. [Auteur]
Anheim, M. [Auteur]
Ruppert, E. [Auteur]
Vitello, N. [Auteur]
Eusebio, A. [Auteur]
Lambert, I. [Auteur]
Marques, A. [Auteur]
Fantini, M. L. [Auteur]
Devos, David [Auteur]
Lille Neurosciences & Cognition (LilNCog) - U 1172
Meriaux, Christelle [Auteur]
Lille Neurosciences & Cognition (LilNCog) - U 1172
Benard-Serre, N. [Auteur]
Lacombe, S. [Auteur]
Vidailhet, M. [Auteur]
Arnulf, I. [Auteur]
Doulazmi, M. [Auteur]
Roze, E. [Auteur]

Journal title :

The Lancet Neurology

Abbreviated title :

Lancet Neurol

Volume number :

21

Pages :

428-437

Publisher :

Elsevier

Publication date :

2022-04-19

ISSN :

1474-4465

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Background Insomnia is a frequent complaint of patients with Parkinson's disease, and it negatively affects quality of life. Drugs that improve both sleep and parkinsonism would be of major benefit to patients with ...
Show more >Background Insomnia is a frequent complaint of patients with Parkinson's disease, and it negatively affects quality of life. Drugs that improve both sleep and parkinsonism would be of major benefit to patients with Parkinson's disease-related insomnia. We aimed to test the safety and efficacy of subcutaneous night-time only apomorphine infusion in patients with Parkinson's disease and insomnia. Methods We did a randomised, multicentre, double-blind, placebo-controlled, crossover trial in 11 expert centres in Parkinson's disease and sleep centres in France. Participants aged 35–90 years with fluctuating Parkinson's disease and moderate to severe insomnia (Insomnia Severity Index score ≥15) were randomly assigned to either first receive night-time subcutaneous apomorphine (up to 5 mg/h) or matching placebo. Randomisation was done using a computer-generated plan in blocks of four, stratified by centre. This first intervention was followed by a 14-night washout period, then crossover to the other intervention. The treatment periods consisted of a 10-night titration phase followed by a 7-night fixed-dose phase. The dose was adjusted during the titration phase on the basis of a daily telephone call assessing sleep quality and treatment tolerability. The primary efficacy endpoint was the difference in Parkinson's disease sleep scale (PDSS) scores from the beginning to the end of each treatment period. Analysis was done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT02940912. Findings Between Jan 31, 2017, and Jan 29, 2021, 46 participants were enrolled. 25 (54%) patients were randomly assigned to receive apomorphine first and 21 (46%) patients to receive placebo first. Mean change in PDSS score was significantly greater with night-time apomorphine infusion (15·18 [SD 24·34]) compared with placebo (5·23 [21·52]; treatment effect 9·95 [95% CI 0·88–19·03]; p=0·041). Adverse events were reported in 25 (54%) participants during the apomorphine period and in 17 (37%) participants during the placebo period (p=0·16). Apomorphine was associated with more frequent dizziness than was placebo (seven [15%] vs 0; p=0·041). Interpretation Subcutaneous night-time only apomorphine infusion improved sleep disturbances according to difference on PDSS score, with an overall safety profile consistent with previous studies in Parkinson's disease. This treatment might be useful to manage sleep disturbances in patients with advanced Parkinson's disease and moderate to severe insomnia.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Submission date :

2024-06-22T22:05:49Z
2024-11-20T09:16:16Z