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Randomized Controlled Trial
. 2023 Oct;270(10):4851-4859.
doi: 10.1007/s00415-023-11814-y. Epub 2023 Jun 20.

Efficacy and safety of clonidine for the treatment of impulse control disorder in Parkinson's disease: a multicenter, parallel, randomised, double-blind, Phase 2b Clinical trial

Chloé Laurencin  1   2 , Noémie Timestit  3 , Ana Marques  4 , Domitille Dilly Duchez  5 , Caroline Giordana  6 , Sara Meoni  7 , Marine Huddlestone  8 , Teodor Danaila  8 , Mathieu Anheim  9   10   11 , Hélène Klinger  8 , Tiphaine Vidal  4 , Marion Fatisson  5 , Catherine Caire  8 , Mikail Nourredine  3   12 , Philippe Boulinguez  13 , Carole Dhelens  14 , Bénédicte Ballanger  13 , Stéphane Prange  8   15   16 , Sylvie Bin  17 , Stéphane Thobois  8   15   16
Affiliations
Randomized Controlled Trial

Efficacy and safety of clonidine for the treatment of impulse control disorder in Parkinson's disease: a multicenter, parallel, randomised, double-blind, Phase 2b Clinical trial

Chloé Laurencin et al. J Neurol. 2023 Oct.

Abstract

Background: Impulse control disorders (ICDs) are frequently encountered in Parkinson's disease (PD).

Objectives: We aimed to assess whether clonidine, an α2-adrenergic receptor agonist, would improve ICDs.

Methods: We conducted a multicentre trial in five movement disorder departments. Patients with PD and ICDs (n = 41) were enrolled in an 8-week, randomised (1:1), double-blind, placebo-controlled study of clonidine (75 μg twice a day). Randomisation and allocation to the trial group were carried out by a central computer system. The primary outcome was the change at 8 weeks in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) score. A reduction of the most elevated subscore of the QUIP-RS of more than 3 points without any increase in the other QUIP-RS dimension defined success.

Results: Between 15 May 2019 and 10 September 2021, 19 patients in the clonidine group and 20 patients in the placebo group were enrolled. The proportion difference of success in reducing QUIP-RS at 8 weeks, was 7% (one-sided upper 90% CI 27%) with 42.1% of success in the clonidine group and 35.0% in the placebo group. Compared to patients in the placebo group, patients in the clonidine group experienced a greater reduction in the total QUIP-RS score at 8 weeks (11.0 points vs. 3.6).

Discussion: Clonidine was well tolerated but our study was not enough powerful to demonstrate significant superiority compared to placebo in reducing ICDs despite a greater reduction of total QUIP score at 8 weeks. A phase 3 study should be conducted.

Trial registration: The study was registered (NCT03552068) on clinicaltrials.gov on June 11, 2018.

Keywords: Clonidine; Impulse control disorder; Noradrenergic system; Parkinson’s disease; QUIP-RS.

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Conflict of interest statement

The authors have no competing interests to declare that are relevant to the content of this article.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
QUIP-RS total score at baseline, 4 and 8 weeks for placebo and clonidine group
See this image and copyright information in PMC

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