Subcutaneous apomorphine infusion promising against insomnia in PD patients

A new study published in The Lancet Neurology showed that subcutaneous apomorphine infusion at night, decreased sleep disruptions based on differences in Parkinson's disease sleep scale (PDSS) score.

Insomnia is a common complaint among Parkinson's disease patients, and it has a detrimental impact on quality of life. Patients suffering from Parkinson's disease-related sleeplessness would benefit greatly from drugs that enhance both sleep and parkinsonism. As a result, Valérie Cochen De Cock and colleagues undertook this trial to assess the safety and effectiveness of subcutaneous night-time only apomorphine administration in Parkinson's disease patients with insomnia.

This was a randomized, double-blind, multicenter, placebo-controlled crossover experiment conducted in 11 French Parkinson's disease and sleep centers. Participants aged 35–90 years old with variable Parkinson's disease and moderate to severe insomnia were randomly randomized to receive either night-time subcutaneous apomorphine (up to 5 mg/h) or a corresponding placebo initially. Randomization was carried out in blocks of four, stratified by center, using a computer-generated scheme. This was followed by a 14-night washout interval before switching to the second intervention. The treatment durations were divided into a 10-night titration phase and a 7-night fixed-dose phase. During the titration period, the dosage was adjusted based on a daily phone call measuring sleep quality and treatment tolerance. The change in PDSS scores from the start to the conclusion of each treatment session was the main effectiveness outcome. The study was conducted with the intent-to-treat principle in mind.

The key findings of this study were as follow:

1. 46 people were registered between January 31, 2017 and January 29, 2021.

2. 25 patients (54%) were randomly randomized to receive apomorphine first, while 21 individuals (46%) received placebo first.

3. When compared to placebo, the mean change in PDSS score was substantially larger with night-time apomorphine infusion.

4. Adverse events were recorded by 25 (54%) of individuals during the apomorphine phase and 17 (37%) during the placebo period (p=016).

5. Apomorphine was shown to cause greater dizziness than placebo.

In conclusion, this medication might help people with advanced Parkinson's disease who have moderate to severe insomnia control their sleep disruptions.

Reference:

De Cock, V. C., Dodet, P., Leu-Semenescu, S., Aerts, C., Castelnovo, G., Abril, B., Drapier, S., Olivet, H., Corbillé, A.-G., Leclair-Visonneau, L., Sallansonnet-Froment, M., … Roze, E. (2022). 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. In The Lancet Neurology (Vol. 21, Issue 5, pp. 428–437). Elsevier BV. https://doi.org/10.1016/s1474-4422(22)00085-0