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Not Yet Recruiting NCT07822893

Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians

Conditions: PARKINSON DISEASE (Disorder)

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 39
Sponsor: University Hospital, Toulouse

Location: Nîmes University Hospital Nîmes

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * Patients with tremors related to a pathology other than PD; * Patients with atypical parkinsonian syndrome; * 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); * patients with atrophy of the target muscle * 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 with marked clinical or subclinical neuromuscular transmission deficits (e.g., myasthenia gravis); * patients with fixed contractures Pregnant or breastfeeding women; * Women of childbearing age without effective contraception; * Patients under legal guardianship, tutorship, or curatorship.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07822893). StuddyBuddy aggregates publicly available trial information.