Botulinum toxin injections for hard-to-treat resting tremor in the arm in Parkinson's disease
Tests Dysport injections against placebo for stubborn arm tremor in Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians
Key facts
- Where
- Nimes Cedex 9 and Toulouse, FranceSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07822893, who can take part
Where in France
- Centre Hospitalier Universitaire De NimesNimes Cedex 9, FranceNot yet recruiting
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT07822893EU 2026-525862-23-00
- Record updated
- 4 November 2026
- Original description
Tremor is one of the most common symptoms in Parkinson Disease (PD), affecting almost 60% of patients. There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex. Botulinum toxin (BT) is widely used in neurology, but few studies have been carried out on the effect of BT in parkinsonian tremor without consensus on its management in parkinsonian patients. In this study, the investigators therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in patients with PD, compared with placebo injection.Read full original descriptionShow less
Evaluation of the Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians, Cross-over Study, Double Blind and Placebo-controlled
Tremor is one of the most common symptoms in Parkinson Disease (PD), affecting almost 60% of patients. There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex. Botulinum toxin (BT) is widely used in neurology, but few studies have been carried out on the effect of BT in parkinsonian tremor without consensus on its management in parkinsonian patients. In this study, the investigators therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in patients with PD, compared with placebo injection.
Inclusion: Patients with PD defined according to UKPDSBB criteria; Men and women aged between 40 and 80 years; Patients with troublesome rest tremor assessed by the CGI-S scale ≥ 3 and persistent despite the initiation of ≥ two anti-parkinsonian treatments (levodopa, dopaminergic agonist, anticholinergic), which defines drug-resistant parkinsonian tremor; Patients naïve to botulinum toxin treatment; Patients whose antiparkinsonian treatment has been stable for at least 4 weeks prior to inclusion and for the duration of the study; Person affiliated with or beneficiary of a social security scheme; Free, informed, and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
Exclusion: Patients with atypical parkinsonian syndrome; patients with a urinary tract infection at the time of treatment if the patient suffers from urinary incontinence due to neurological detrusor overactivity; patients with a history of swallowing or respiratory disorders; Patients treated with drugs which have the adverse effect of causing the appearance or aggravation of tremors: lithium, sodium valproate, levetiracetam, benzodiazepines, corticosteroids, thyroid hormones, ciclosporin, alcohol, tricyclic antidepressants, theophillyne, terbutaline, antipsychotics (excluding clozapine) ; Patients with hypersensitivity to the active substance or to one of the excipients (human albumin, lactulose); Women of childbearing age without effective contraception; Patients with tremors related to a pathology other than PD; patients with atrophy of the target muscle; patients with marked clinical or subclinical neuromuscular transmission deficits (e.g., myasthenia gravis); patients with fixed contractures Pregnant or breastfeeding women; Patients under legal guardianship, tutorship, or curatorship.